Document 6425768

September
1995
PSYCHIATRIC
LRWCE S
A Journal
American
of the
Psychiatric
Association
Formerly
Community
A National
the
Study
of
Effectiveness
of
Mobile
Crisis
A New
Mental
Colunm
Health
on
Care
in the
States
‘Reform
Command
and
f
the
of
Hallucinations
Likelihood
Dangerous
Hospital
Behavior
Readmission
Female
With
Services
Veterans
Substance
Abuse
Hospital
Psychiatryand
HALDOL#{174}
Decanoate
(HALOPERIDOL)
Offer
INJECTION
your
100
100 mg/mL
patients
the
most
consistent
relapse
protection
4
Establish
a safe, effective
How Much?
How Often?
How
Patients
who are Stabilized
Ofl oral doses
:S1O mg/day,
who are elderly,
or who are debilitated2
Patients who are maintained
on oral doses
>10 mg/day,
who are tolerant
to oral medication,
or who are at risk for relaps&
Initial month’s dose is 10 to 15 times patient’s daily oral dose*2
Initial month’s
daily oral dose*2
100 mg, the balance of the first month’s dosage can be administered
Total monthly dose should not exceed 450 mg
#{149}
Maximum volume per injection site should not exceed
U
*Supplementation
10 to 15 times daily oral dose depending
with oral haloperidol
Decanoate
3 to 7 days later
For
is a brisi mnwy
only. k$ors isc#{241}bk,s
Decanoate
3 mL
on clinical response2
can be used during periods ofdose
50 I HALDOL
(hr$dol)
1IsiM
should not exceed
dose is 20 times patient’s
U
Maintenance
0
T
dose
#{149}
Once a month
#{149}
Since the first injection
High?
HALDOL
oral haloperidol
adjustments
I 00
(hr$doI)
$con
cempe
uc
Mdonnatlon
10 to 15 times daily oral dose depending on clinical response2
#{149}
1120 times the daily oral dose is used, monthly dose should
be reduced based on clinical response (by approximately
25% of the original dose, each month for 2 months) until
appropriate maintenance
dose is reached3
U
HALOOLai HALDOLDecaloats
ONTRAIOOICAT1OItSrnce me pharmacog and chnc abo of KALDOIDecanoate50 and HALDOIDecanoate 1 are attnbuted to
HALDOIhaIopend
the activemethcatmn,CONTRAINICATIONS,
WARNINGS.ai addmon intomiahon are those ot HALDOLmodthed
to reflect the pronged actn. HALDOLo cOdTarnd
in severe toot centr nervous syslero depression or comatose states from any
causear in ndrviduas whoare hypersensitrto ho drug or have Parlonson’sdsee.
WARNINGS:TaithoS D#{216}ioaia:
Jordandonesa a syndrome constrr
potent
rreverob, nvuntary, dysnet mments may
develop in patents treatt ecth aobpsyctiohc drugs though the preva’enceof the syndrome appears to hhest among the eldenty,
ciaOyetdey women, 6 imposob to ry upon prevalenceOnt
to predict, at the ncepon ofaobps#{216}otic
treatment w$rfl patients are
Iy to devop the syridronre.ether aopsychoc dregprodocis ddter in then pOter to canoe tardne dysnema unknown. Boththe
osk of developrngtarthve dyskoresiaand the bkehhoodthat d willbecome irrevemibe are heaved to increase
as the durahon oftreatment and
the totd cumuhve dose of aotc
dnigs minndered tothe patientincrease. Hover, the syndronrecan devetop,although much ss
commordy, after rendy heel treatment s
at w doses There no known treatment for eStahnd cases of tarthve dndones
although fe syndrome may remit. itiaI$y or compteteIy d anhpsychnd treatment rewithdrawn.Mtipsychotic treatment dselt.
may
suppress (or
suppress)ttre sqns and symptoms ofthe syndrome aid thereby may possy mask the undedym9 process The effect
that syrnptomatc suppremaon h upon the ngterm course of the syndmme o unknown. Gn these condemhons, aItS#{216}OtE
dni
shotddbe prrecrthedma mannerthato most liheyfo minimoe the occurrence ofhede dyskinesia Ghron acthpshohctreaheeN shou
generaty be reservrelfor pahen who suttenfrom athron knessth 1)6 kflOWflto reSPOfldtoaflhpSyChOhC
drugs, and 2)torwhorn afterrre
tree. equaty eflechve,but potentiy ss twmtUt treatments are m avadabe orappropdate. In paben who do reqtarechrorec treatment the
snndst dose and the shortest durahon oftreatment producanffa satretactorydrec response shoidd he sotht the ne for coetmued heat
mendshcoid he reassessed eiy
Uogro and synmoma oftarthve dysnesiaappear ina pabenton aohpsychohcs, drug docOchnUahOn
shoo be considered. Hover, snare patients may require treatment despde the presence ofthe syndmme. (For further informahonaboot the
descnphenof tardan dysnesiaaod dsdini detechon, ease referto ADVERSEREACTIONS.)
NsurIc
Mat
$omo
(N
A pOtentiaffytahe symptom compeo somehmre referred to as NeUrOIept Mahgnant Syndreme
)NMS)h been reportedin socndme ndthanhpsychOtc dnigs. Ghroc mandeshoem of NMSare hyperpyrer moscN rfly, ahernd men
he status(inctuthr catatomc ogns)and credenceof aotonomc ffistady)wrear
puheor Nood pressure tachycarth dhoresre, and car
dysihythnnian).AddthonndS19fl5may irctu elevatedcreabre phospholanase, myngtobnur)thabdomyos)and
arote mindtadure. The
thagnosoc evahiation ofpatents with ho syndrome comnd.
InarrMng at a thagnosis, 0 mpornt to enhty cases where the chnc
presernahon endudes both sermon mnd ilness)e g, pneumona syntem intechon,etc)aod untreatrelorinadequaheyheated ectmpyrami
d ogns and symptoms )EPS).Other impornantconoderahons n the dd?erentnddnoso indude centr anhchohnergEtmdc4 heat stroke,
dreg feverand pnnwy centok nervota system CR5) pathstogy. The maroement of NMS thou endude 1) immedst dkeoohnuahoo of
anbpsychotc dnigs and other dregs nst essentnd to concUrrentthery, 2) intensivesymptomabc treatment and methcst mondoflng, and
3)treatmerd ofanyconcomdant sedous medist proNemsforwhch specAc treatmenareavadabi Thereo nogenerst memerdakostsn
cthcpharmacotrcst treatment reimeos for uncnmphcatedNMS.Ua paherd reqUiresanhpsychohc drug treatment after recoveryfrom NMS,
the potentndrnntroduchon of dreg therapy shoust hecarefUffycOnSideOndThepaherdshootr hecaretoky mondorod,some recorrencroofNMS
have keen reported. Iypeipyremaand heat stroke. rotsociated wok theabove symptom complex,haveatso keen reported wok HAIDOL
Deep a Pmiaucy)sec PRECAUTIONS
- Usage in Pregnancy)
C.m
Uoa WOhLiDeoec)sec PRECAUTiONS-Drug
Interachons)
Geooral: Bronchopneumon sometimes fahe, has f000weduse of anhpsychotc drags, indudieg hstopendoi Prorn rennedndtherapy shostd
he instdotnd d dehydration, hemoconcentrahon or reduced polmonary venthhon occor, ropecahy in the estedy. Dweasrel senim chOinsteist
and/or cotanecaa and ocular changes have been reponikewith themca1yrekend drags, although nOioath tnlopendo&See PRECAU1ONS
IntormahontonPahentotor intormahonon mend and/or phyncOiOiahbesandon concomdant osewdh othersobstances.
PRECAUTIONS:Mminrster casteously to paben 1) oath severe carthovascotar doorders, due to ftre possMy of tranreent hy$ensoto
aOd/O1prepdahon ofangonotpnn)d avanopressor o regarred,nsphnnsshouki not he nnd once HALDOLmay OiockHsvasopressorxtrv
ny and paradootcotfurther tawenng of strandpressure may OcCUTmetararmnol,phenytephnneor norepmeph#{241}ne
shoost he Used): 2) receng
anhconvukanf medcations, oath a hndoryof seoures or wdh EEGabnomnatthes,because HALDOImay tewer the sononteob threshote. HinOi
caSed,adequateanbconvutsatflthery shouki be concomHAnfly
mOinkened.)3)wdfr knownaIIerg ora historyat aterg reachons to drags;
)4) receiving anticoagulaots, since an isolated instance of interference occurred ndththe effects of one anticoagulant )pheoindione).
Concomdantanhgsdonsonmedcahon,d reqoired may hare to hecontanoed after HALDOLo doconbnued becaUseot&fferentencrebon rates;
d both are doconhnued omuffaneousty,extrapyranndotsymptoms may occur.Intraocoterpressure may recrease when anhthohnerg drog
inchotinganfrgsrtrnson drugs, are admiotetenedconcomoanhy wdh HALDOLWhen HALDOLo used ton montein tapotar dteorders there may
be a rapot mood ong to depresroon. Severe neorotoobdy may occur in pabento wok thyrotooicosrorecnvir anhpsychokc medtrahon,
vekotmg HALDOL.
WaoaaOoa
Nt PatWat Menhe and/or phyncot abdthes requirndton hazardoirolarks or dnvmg may be impaned. Aicohotshou he avoided
dueto posrabtealdthve efIectSarOihypotenoon
0mg etoraOiIoo Potnte recenang lithomptrs hatependot shoont he morotored ctasotyfor andy eradenceof neurOiogOi toxctty and treOi
meit doconbnoed promphyd such ragosappear As ante otheranhpsychohc agents. Cshoute be noted that HALDOLmay he capatre ofpotenRahegONSdePreSSantSSIJchananesthetea, oprat andalcohot
caroMoii
agsosais
W iploasat of FesIIII No mutenc potenhal of halopendolwan found n the Ames SalmoneOanalcnosonok achvaflonassay. Negaton or inconrastentposthve Indrogs have been obtamed in ro vntroaod ro v studes of effects of halopendoton
chromosome structure and numher The available cytogenetic evidence is considered too inconsistent to be conclosive at this frme.
Carnogencity otodmousreg oral hato
were cOndUCtndm Wotar rats )dooedot op to 5 nngOcgdoty for 24 montho)and mAlbinoSwtes
nace)dosedatupto5mgthgdadyhe
l8months). InffrertestudysumeOiwankesthanophmalinaOdosegmu
redtegftrenumherof
ratsat nob tondevelopoegtUmors.HoOnver,althougha retahvetygreoter nUmberof rats survoed to the oral ofthe study inh#{231}h
dose male nd
temah groups these enmals dot not have a greatenincotenceofturnors than controt anmials. Therefore,Oithn4
npknnaEthi shadydoes
sUgg the absence of a halopefldotrotatedincrease n the orcadenceof onoptesrain rats at doses op to20 Drossthe Usualda honnandose
for chrorecor resistant patents In femate race at 5 and 2Obmesthe hheOi inthaldadydosefnr chroracor restetard pahents, there wan astahskcaffyo#{231}mhcant
increase in mammary gOod oeopia and total tumor incotence,at 2dtimeo the same doty dose there wan a StOiohcaRy
sqnhcant rease in pituhary gtexl neoplana In male m. no statishcallysigniffcantdffferencesm UncAlencesof total tumnrs or specific
flimortynes ecre noted Antcsychokc drags etevateprotachn hoots; the otevabonpenrastsduneg thronc ndministraion. Thoon cofloreaspenmentr iothcatethat approobmatelyone-third of human freest cascara are protactArdependent Ar*n, a factor of padentot impeitance Hthe
until steady state has been achieved.
prescnption of these drugs o contemptated in a pahent witha previouslydetected breast cancer. AlthoughOisturbancessuch as galactnnrhea
.q,
amenoarhea gynecomasti and linpotence tave taen reported, the diotcalognificance nfelevated serum prnlacbnlevelsniunknownfvr most
pabents. Ar increase ni mammary neo#{216}asros
has been found in rodents after chroen wiminibahon of anfipsychoficdnag Nelther dtek
chides nor epniemknog studes conducted to date, hnweoer, haveshown an assocnhnn betweenchronc idmiontrabnn of these drugs and
mammaiytumvdgeveste: the aVadableevidenceisconsidered too tended to be concluoveidthibme
(leap to Proq.anc PregnancyCategoryC.Safe use inpregroocyorir women hkelyto become pregnant has not been estabitehed;use onlyH
benefitdearfy jusohes potenhalhazardstothefetus.
NurelogNathoet lnfavitsshnuktnot be nursed dump dnigtreatment
PodiatrIc Uoa:Controted tniatstoestabhofrflesabetyand effechvenessof intrannoscularudministrabonni chntren have not been cOndUCt
ADVERSIREACTIONS:Adverse macboos fotowoag the admirestratoanof HALDOLDecannate 50 or HALDOLDecanoate 1HAam those of
HALDOLhalvpeddoi Since vastespernince hasaccumutated wdh HALDOLthe adverse reachoirsare reported fonthaf compound as wet asfor
halopeddoldecanoate.Mwfihat nictable methcafions,tucalhssue reachom havebeen repvrfedwoh halopeddotclecanoate.
ciis m.et Eaha&
Sl#{216}ms($)- EPSdufleg fleadiroOnitrahOnof HALDOL)honpeddel)have been reported frequenfly,often
duneg the first few days of treatment. EPS can be categoncied generally as PadAnsvnhke symptoms. akathnii or dystoma (inckntieg
opisthotonos and cn2Hogyriccrisis). Wink at can occur at relativelytrw doses, they occur more frequentlyasotwith greater severityat higher
doses. The symptoms may be contmted withdose reductions or udmimstrahonof anhparlunson drugs such as berrztmpmemesylate USPor
tHhenyenrochtundeUSP.ftshoulebeoofwithidpersniteMEPShavebeerrepoded;thednigmpohavetnbedtuconfiouedinsucfr
cases. WhdrawaI Emsepid NsoreIocaI $ns - abrupt detconfinuation of short-term ath-psychofc therapy te generally uneventful
However.some pabents on malntenance treatment espeflence transient dystunehosigns after ahrud withdrami. In certan cases these are
indofingunhabte from ‘TardnieDyntunesa”except for donahue.ft s unknownwirether gradual withdrami wdlreduce the occurrence of these
ogns but urtd further eordenceni avidalde HALDOIshoutu be graduallyeithdrawn.Taatlvo DetJosia - As with at anfipsychuhougents
HALDOLhas beenassocoted wtffrperslstent dyskinesnis TardNedyOiunes asyndrnmeconstubng ofpotenbaftylnovenOib involuntary,dys#{149}
tanehc mmennents, mayappear in some pabentson tang-tametherapyormay occurafterdrug therapyhas beendelconfinued.The dskappears
to begreaten nielderlys
on high-dose therapy,especratyfemales. Thesymptomsare persisterdand in some pahenfsappearirrewnsthle
The syndrome s characterized by rhythmmi rovokintarymevements of tongue, face. mouth or w (e.g., protroslon of tongea puffing of
cheetu. puckenng of mouth. cIrce-mg mowrnrents(.Somefimes these may be accom
tr invotuntarymovements of eutremdho and the
trunk There s no known effectud treatment for tardok dystunenic anfipa’fdnsonagents usually do not alleotatefire symptoms of Des syndmme. Unisuggested that all aobpsychOhCagents be dhiconbnuedHthese symptoms appear. Should ft be necessary to ntnStdUtetreatment
or increase the dosage of the agent or switch to a ddferent anfipsychoficugeot, this syndrome may be masked. ft has been reported that fine
verncubr movement of the toegue may be an earlysign of tardsle dystunesniand Hthe methcattm nistopped at that fine the fuRsyndrome
may not develop.Taattw Dyatoula - Tarthvedystnna not assncated with the above spodmee, has also been reported. Tardho dyntornani
cfraractenniedbydel
onsetofchormc ordystonc movements, s often pernistent,and hasthepotenbal of becomsrg irreversdae. OIeeIlS
E1ods - Insomni restlessness, anolety,euphora agelahon,dmwniness, depresslon, lethargy, headache, conhisnin, vertigo, grand mat
seniure and enacerbabon ofpoychoto symptoms indudiug hafluanahons, and catatonk-hke behaofnudstates whtrh may be responrave to
drag oethdra aod/ortreatrnent withaobchOiinerg drugs.
Body as a Whotc Neuroleptc malignantsyndrome (hitS), hyperpyrextewnl heat stroke have been reported wtfhHALDOL.(See WARNINGS
forfurtfrer erformaboinconcenniegNtIS.)
Caedlevascati Efto Tachycardi hypotensoto, hypertensninand EcG changes, ndud prtAongabnnof the 01 inteevatand EOGpattem
changescnmwith
the polymorphousconfigurafionoftorsades do pnintes.
I$smaI
Eftsc Reports ofmild, usually transient leukOpemaand leokocytosm,minimaldecreases in red blood ceUcourt anemia or a
tendencytowerd lymphnmnnocyfnsni;agomutucy1nshirarelyreportedarni only inassociahon withOthermediabOn.
I
Lles,Eflsc Impanedhwntancbonand/orpurebce.
DonRaIoi*DeactIsot Mwtupegukeandamedono macfloes,sotated esofphntosensHMly, tess of han.
Endocetas Dlesedsec Lacfabon,breast engorgement nrastalga menstrual irreguhafies, gynrecoanasbaimpotence,increased fibeto, hyperglycemihypoglycerniiaaodhyponatrenna
Mntconsbpahon,dtarrheahypemahvidnir,dyspepsi
ouoreaandvomhag
AatoaooeicReaethiut Dryrnouth. oturredvision,unitary retention,diaphoreste,and pnugisirr.
RisoiyEfls
Laryngospasnr,bronctrnspasnnand uorreaseddepth ofrespirafion.
Special Ssoae Catazfs. rehnOpathyandVioUaldteturbaoces.
4
QUeerCases ofsudden and unespecleddeath havebeen reported inassodabon withthe idmiotetrationof HALDOLThe nature ofthe enidence
mattes H imposnibleto determine doflndly what rn Hany, HALDOLptayed in fire outcome of the reported canes. The POSSAlAHYthat
HALDOL caused death cannot of course. be erniuded, but ft nito be ked n wind that sudden and unexpected death may occur ni poychofic
pahentswhentheygs untreated orwiren tmyamtrealed withOtherantmpychOl(drags.
Psad
Ewoi Hyperammonerna has been reported in a 5/i ynar ote chat with dtrutiner* an onherdeddteonter of ammonia excre
boo, fONhongtreatmerftwithHALDOL.
4
UPORTANT:Fell Smedoitthamakootd
as road batote NALD orHALDOLDecanoats praduetsaro admlolstsrW eeproscelbod.
Fot*miaNeo oosvor*msaod
troataoatrAovsrisaaos,ssslell
pescdiaa *noatlot
.
.
TtnJwt.Jrvr
HAtflflt Ntstifnrm
nv*and1mifn
Retercnce:
1. DavisJM,
KaneJM,
Mrder
SR. er a]. Dose
HALDOL#{176}
Decanoare Packige 1ricrr. McNeil
Lyman RC, SakId SR. Anderson CO. RJCIWdS AL
2.
Ansixiarion
144th Annual
Menting.
May
C
991;
PHARMACEUT1CL
M
O8HO29B/O2-t4-95
NEWJEROEYOOOO2
response
Pharmaceiirkal.
o1prophyIcric
aiiripsychotics.J
C/in Piycbiatry.1993,54(suppl 3):24-30.
Spring House, PA 19477. Revised 10/13/92. 3. Ereshefsky1. Toney G.
Halopcndoldeunoanc:
New Orleans.
an dTeaine
&sing
snratcgy. Prenented
an the Arnencan
Psyclnatnc
La.
:
SCIOS
poaooeceanic*s
NOVA
4
-
HALDOL
Provides
the
protection
no increased
with
relapse...
risk of side
from
as compared
F
X T F N I) I N
(;
P
ConSiStent
mOSt
to oral
R 0 1 F C T 10
N
therapy
FRoI
HALDOL#{174}
Decanoate
(HALOPERIDOL)
1)
\1 ‘Ni
1
1
\l
l\(
INJECTION
H
(II
II
effects
RFIAPsE
100
100 mg/mL
?
1’
.c
I,,.
ONCE-DAILY
PAKIE
PAROXET/NE/-IC!
References:
GC. Cohn JB, Fabre LF, et al. BrJPsychiatry
1991;159:394398. 2. Cohn JB, Wilcox CS. J Clin Psychiatry. 1992;53(suppl):
52-56.
3. Feighner JP, Boyer WE J Clln Psychiatry. 1992;53(suppl):44-47.
4. Fabre LE J Clin Psychiatry. 1992;53(suppl):40-43.
5. Sheehan D,
Dunbar GC, Fuell DL. Psychopharmaco/Bull.
1992;28:139-143.
6. Clayton PJ, Grove WM, Coryell W, et al. AmiPsychiatry.
1991;148:
1512-1517. 7. Paxil (paroxetine
HCI) Prescribing
Information.
1. Dunbar
PAXIL#{174}
(brand
S..
of parox.tine
hydrochiorid.)
complat.
prescribing
information
in SmfthKIin.
Becham
Pharmac.utical. Iitraturs
or PDR. Th. following is a brief summary.
INDICATiONS
AND USAGE: Paxil is indicated for the treatment of depression.
CONTRAINDICATIONS:
Concomitant
use in patients taking monoamine
oxidase
inhibitors (MAO(s) is contraindicated.
(See WARNINGS.)
WARNINGS:
Intaractions with MAOIs may occur. Givan th. fatal int.ractions
rported
with
concomitant
or imm.diately
consacutiva
administration
of
MAOIs and othar SSRIs, do not usa Paxiin
combination
with a MAOI or with.
In 2 waks
of discontinuing
MAOI tr.atmant.
Allow at I.ast 2 w.ks
aftar stop.
ping Paxil b.for.
starting
a MAOI.
PRECAUTIONS:
As with a)) antidepressants,
use Paxil cautiously in patients with a
history of mania.
Use Paxil cautiously in patients with a history of seizures. Discontinue
it in any
patient who develops seizures.
The possibility of suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high-risk patients should accompany
initial drug therapy. Write Paxil prescriptions for the smallest quantity of tablets consistent with good patient management
in order to reduce the risk of overdose.
Reversible hyponatremia
has been reported, mainly in elderly patients, patients taking diuretics or those who were otherwise volume depleted.
Clinical experience with Paxil in patients with concomitant systemic illness is limited. Use cautiously in patients with diseases or conditions that could affect metabolism or hemodynamic
responses. Observe the usual cautions in cardiac patients. In
patients with severe renal impairment (creatinine clearance <30 mL/min.) or severe
hepatic impairment, a lower starting dose (10 mgI should be used.
Caution patients about operating hazardous machinery, including automobiles,
until
they are reasonably sure that Paxil therapy does not affect their ability to engage in
such activities. Tell patients 1) to continue therapy as directed; 2) to inform physicians about other medications they are taking or plan to take; 31 to avoid alcohol
while taking PaxiI 41 to notify their physicians if they become pregnant or intend to
become pregnant during therapy, or if they’re nursing.
Concomitant
use of Paxil with tryptophan is not recommended.
Use cautiously with
warfarin. When administering Paxilwith
cimetidine, dosage adjustment of Paxil after
the 20 mg starting dose should be guided by clinical effect. When co-administering
Paxil with phenobarbital
or phenytoin, no initial Paxil dosage adjustment is needed;
base subsequent
changes on clinical effect. Concomitant
use of Paxil with drugs
metabolized
by cytochrome
P4llDv
lantidepressants
such as nortriptyline,
amitriptyline, imipramine, desipramine and fluoxetine; phenothiazines
such as thioridazine; Type 1C antiarrhythmics
such as propafenone,
fecainide and encainide) or
with drugs that inhibit this enzyme (e.g., quinidinel may require lower doses than
usually prescribed for either Paxil or the other drug; approach concomitant use cautiously. Administration
of Paxil with another tightly protein-bound
drug may shift
plasma concentrations,
resulting in adverse effects from either drug. Concomitant
use of Paxil and alcohol in depressed patients is not advised. Undertake concomitant use of Paxiland
lithium or digoxin cautiously. If adverse effects are seen when
co-administering
Paxil with procyclidine,
reduce the procyclidine dose.
In 2-year studies. a significantly greater number of male rats in the 20 mg/kg/day
group developed
reticulum cell sarcomas vs. animals given doses of 1 or 5
mg/kg/day.
There was also a significantly increased linear trend across dose groups
for the occurrence of lymphoreticular
tumors in male rats. Although there was a
dose-related
increase in the number of tumors in mice, there was no drug-related
increase in the number of mice with tumors. The clinical significance of these findings is unknown. There is no evidence of mutagenicity with Paxil.
Serotonergic
compounds
are known to affect reproductive
function in animals.
Impaired reproductive function in rats (i.e.. reduced pregnancy rate, increased proand post-implantation
losses, decreased viability of pups) was found at Paxil doses
15 or more times the highest recommended
human dose.
Pregnancy
Category
B. Reproduction
studies performed
in rats and rabbits at
doses up to 50 and 6 times the maximum recommended
human dose have revealed
no evidence of teratogenic effects or of selective toxicity to the fetus. However,
there are no adequate and well-controlled
studies in pregnant women. Paxil should
be used in pregnancy only if the benefits outweigh the risks. The effect of Paxil on
labor and delivery in humans is unknown. Paroxetine is secreted in human milk;
exercise caution when administering
Paxil to a nursing woman.
Safety and effectiveness
in children have not been established.
In worldwide Paxi/clinical trials, 1 7% of Paxi/-treated patients were 65 years of age.
Pharmacokinetic
studies revealed a decreased clearance in the elderly; however,
there were no overall differences
in the adverse event profile between older and
younger patients.
ADVERSE
REACTiONS:
lncid.nc.
in Controlled
Trials-Commonly
Observed
Adverse
Events
In Controlled
ainical
Trials: The most commonly
observed
adverse events associated with the use of Paxil(incidence
of 5% or greater and mcidence for Paxil at least twice that for placebo): asthenia (15% vs. 6%), sweating
(1 1% vs. 2%), nausea 126% vs. 9%), decreased appetite (6% vs. 2%), somnolence
123% vs. 9%). dizziness (13% vs. 6%), insomnia (13% vs. 6%(, tremor (8% vs. 2%),
nervousness
15% vs. 3%), ejaculatory disturbance (13% vs. 0%) and other male
genital disorders 110% vs. 0%). Twenty-one percent 1881/4,126) of Paxi/ patients in
worldwide
clinical trials discontinued treatment due to an adverse event. The most
common events l1 %l associated with discontinuation
and considered to be drug
related include: somnolence,
insomnia, agitation, tremor, anxiety, nausea, diarrhea,
dry mouth, vomiting, asthenia, abnormal ejaculation, sweating. The following adverse events occurred in 6-week placebo-controlled
trials of similar design at a frequency of 1 % or more.
Body as a Whole: headache, asthenia, abdominal pain, fever, chest pain, trauma,
back pain. Cardiovascular:
palpitation, vasodilation, postural hypotension. Dae’matologic: sweating, rash. Gastrointestinal:
nausea, dry mouth, constipation,
diarrhea, decreased
appetite, flatulence,
vomiting, oropharynx disorder, dyspepsia,
increased appetite. Musculosklatal:
myopathy, myalgia, myasthenia.
Nervous
System: somnolence,
dizziness, insomnia, tremor, nervousness, anxiety, paresthesia, libido decreased,
agitation, drugged feeling, myoclonus,
CNS stimulation,
confusion. R.splratlon:
respiratory disorder, yawn, pharyngitis. Special S.ns.s:
blurred vision, taste perversion. Urogenital
Syst.m:
ejaculatory disturbance, other
male genital disorders,
urinary frequency,
urination disorder, female
genital
disorders.
Studies show a clear dose dependency
for some of the more common adverse
events associated with Paxil use. There was evidence of adaptation to some adverse events with continued Paxil therapy (e.g., nausea and dizziness). Significant
weight loss may be an undesirable result of Paxil treatment for some patients but,
on average, patients in controlled trials had minimal (about 1 Ib) loss. In placebo-controlled clinical trials, Paxi/-treated patients exhibited abnormal values on liver function tests no more frequently than placebo-treated
patients.
Other Ev.nts Observed
During the Pr.mark.ting
Evaluation
of PaxII During
premarketing
assessment,
multiple doses of Paxil were administered
to 4,126
patients, and the following adverse events were reported. Note: frequent
= events
occurring in at least 1/100 patients; infrequent
=
1/100 to 1/1000 patients; rare =
less than 1/1000 patients. Events are classified within body system categories and
enumerated
in order of decreasing frequency using the following definitions. It is
important to emphasize that although the events occurred during Paxil treatment,
they were not necessarily caused by it.
Body as a Whole: frequent: chills, malaise; infrequent:
allergic reaction, carcinoma,
face edema, moniliasis, neck pain; rare: abscess, adrenergic syndrome, cellulitis,
neck rigidity, pelvic pain, peritonitis, ulcer. Cardiovascular
System: frequent: hypertension, syncope, tachycardia; infrequent: bradycardia, conduction abnormalities,
electrocardiogram
abnormal, hypotension,
migraine, peripheral vascular disorder;
rare: angina pectoris, arrhythmia, atrial fibrillation, bundle branch block, cerebral
ischemia, cerebrovascular
accident, congestive
heart failure, low cardiac output,
myocardial
infarct, myocardia)
ischemia,
pallor, phlebitis, pulmonary
embolus,
supraventricular
extrasystoles,
thrombosis, varicose vein, vascular headache, vontricular extrasystoles.
Digestive
System:
infrequent: bruxism, dysphagia, eructation, glossitis, increased salivation, liver function tests abnormal, mouth ulceration,
rectal hemorrhage;
rare: aphthous stomatitis, bloody diarrhea, bulimia, colitis, duodenitis, esophagitis, focal impactions, focal incontinence,
gastritis, gastroenteritis,
gingivitis, hematemesis,
hepatitis, ileus, jaundice, melena, peptic ulcer, salivary
gland enlargement,
stomach ulcer, stomatitis, tongue edema, tooth caries. End.cnn. System: rare: diabetes mellitus, hyperthyroidism,
hypothyroidism,
thyroiditis.
Hemic and Lymphatic
Systems:
infrequent:
anemia, leukopenia, lymphadenopathy, purpura; rare: abnormal erythrocytes,
eosinophilia, (eukocytosis, lymphedema,
abnormal lymphocytes,
lymphocytosis,
microcytic anemia, monocytosis, normocytic anemia. Metabolic
and Nutritional:
frequent: edema, weight gain, weight loss;
infrequent:
hyperglycemia,
peripheral edema, thirst; rare: alkaline phosphatase
increased,
bilirubinemia,
dehydration,
gout, hypercholesteremia,
hypocalcemia,
hypoglycemia, hypokalemia, hyponatremia,
SGOT increased, SGPT increased. Mus.
culoskelatal
System: infrequent:
arthralgia, arthritis; rare: arthrosis, bursitis, myositis, osteoporosis,
tetany. Nervous
System:
frequent: amnesia, CNS stimulation,
concentration impaired, depression, emotional lability, vertigo; infrequent: abnormal
thinking, akinesia, alcohol abuse, ataxia, convulsion, depersonalization,
hallucinations, hyperkinesia,
hypertonia, incoordination,
lack of emotion, manic reaction,
paranoid reaction; rare: abnormal electroencephalogram,
abnormal gait, antisocial
reaction,
choreoathetosis,
delirium,
delusions,
diplopia,
drug dependence,
dysarthria, dyskinesia, dystonia, euphoria, fasciculations, grand mal convulsion, hostility, hyperalgesia,
hypokinesia, hysteria, libido increased, manic-depressive
reaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus,
paralysis, psychosis,
psychotic depression, reflexes increased, stupor, withdrawal syndrome. R.spirato‘V System:
frequent:
cough increased, rhinitis; infrequent: asthma, bronchitis, dyspnea, epistaxis, hyperventilation,
pneumonia, respiratory flu, sinusitis; rare: carcinoma of lung, hiccups, lung fibrosis, sputum increased.
Skin and Appendages:
frequent: pruritus; infrequent: acne, alopecia, dry skin, ecchymosis, eczema, furunculosis, urticaria; rare: angioedema,
contact dermatitis, erythema nodosum, maculopapular rash, photosensitivity,
skin discoloration, skin melanoma. Special Senses:
infrequent: abnormality
of accommodation,
ear pain, eye pain, mydriasis, otitis
media, taste loss, tinnitus; rare: amblyopia, cataract, conjunctivitis, comeal ulcer,
exophthalmos,
eye hemorrhage,
glaucoma, hyperacusis, otitis extema, photophobia. Urogenital
System:
infrequent: abortion,
amenorrhea,
breast pain, cystitis,
dysmenorrhea,
dysuria, menorrhagia,
nocturia, polyuria, urethritis, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare: breast atrophy, breast carcinoma, breast neoplasm, female lactation, hematuria, kidney calculus, kidney function abnormal, kidney pain, mastitis, nephritis, oliguria, prostatic carcinoma, vaginal
moniliasis.
Postmarketing
Reports
Voluntary reports of adverse events that have been received since market introduction and not listed above that may have no causal relationship with Paxil include
elevated liver function tests (the most severe case was a death due to liver necrosis, and one other case involving grossly elevated transaminases
associated with
severe liver dysfunction), toxic epidermal necrolysis, priapism, thrombocytopenia,
syndrome of inappropriate ADH secretion, symptoms suggestive of prolactinemia
and galactorrhea,
neuroleptic
malignant
syndrome-like
events; extrapyramidal
symptoms which have included dystonia, akathisia, bradykinesia, cogwheel rigidity, hypertonia, oculogyric crisis (which has been associated with concomitant
use
of pimozide), tremor and trismus; and serotonin syndrome,
associated in some
cases with concomitant use of serotonergic drugs and with drugs which may have
impaired
Paxil metabolism
(symptoms
have included
agitation,
confusion,
diaphoresis,
hallucinations,
hyperreflexia,
myoclonus,
shivering, tachycardia and
tremor). There have been spontaneous
reports that abrupt discontinuation
may
lead to symptoms such as dizziness, sensory disturbances,
agitation or anxiety,
nausea and sweating; these events are generally self-limiting.
DRUG ABUSE AND DEPENDENCE:
Controlled
Substance
Class: Paxil is not a
controlled substance.
Evaluate patients carefully for history of drug abuse and
observe such patients closely for signs of Paxil misuse or abuse (e.g., development
of tolerance, incrementations
of dose, drug-seeking behavior).
BRS-PX:L8
SB
SmsthKlsn.
Philadelphia,
Bescham
PA 19101
JANSSEN
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46
No.9
RAPID
STABILIZATION
AND
TREATMENT
BIPOLAR
IN
OF
DISORDER
PSYCHIATRIC
THE
EMERGENCY
SERVICE
12noon 2:00pm
-
Fday,October6, 1995
Industry
supported
luncheon
Symposium
1
CHARIPERSON:
Pnin 1.FORSTER,
M.D.
PRESENTERS:
PAULE.KFIX,JR.,M.D.
MARKA. FRYE,
M.D.
I
I
-
j
L
A SELECTIVE
SEROTONIN
INHIBITOR
REUPTAKE
DEMONSTRATED
COMPULSIONS
RAPIDLY
EFFECTiVE
IN RELIEVING
IMPRISON
PATIENTS’
AND
MINDS1*
BLOOD
LEVELS;
HALF-LIFE’
INCIDENCE
LOW
STEADY-STATE
ACHIEVES
SHORT
OBSESSIONS
THAT
FAVORABLE
OF AGITATION
SAFETY
(2% vs 1% for placebo)’
PROFILE
#{149}:#{149}
Relatively low incidence of anticholinergic
side effects in controlled trials of OCD and depression,
LUVOX Tablets vs placebo’: dizziness 11% vs 6%; constipation 10% vs 8%; dry mouth 14% vs 10%
#{149}:#{149}
The most commonly observed adverse events compared to placebo were somnolence 22% vs 8%,
insomnia 21% vs 10%, nervousness 12% vs 5%, nausea 40% vs 14%, abnormal ejaculation 8% vs 1%,
asthenia 14% vs 6%’
+ Concomitant
use of LUVOX” Tablets and monoamine oxidase inhibitors is not recommended’
FLEXIBLE
Initial
DOSING
Dose: 50 mg once
#{149}4.H
*Lj
j
a day HS
50-mg tablet
#{149}
Increase
i#{174}-mgtailet
#{149}BID
dosing
SAFETY
COMPREHENSiVE
Dose Range:
DATABASE
100 to 300 mg/day
by 50-mg
ilicrements
recoI1mended
as needed
for over 100 l1g/dav
(World4de Exposure for Reporting Overdose
#{149}#{149}
Data from 40 countries
+
Over 9 million patients
+
More than 37,000 patients studied in clinical trials
treated
LUVOXT
IIuvoxamine
maeate
TARGETED
TREATMENT
FOR OBSESSIONS
AND
Effectiveness not established beyond 10 weeks in controlled ulals.
tprescribers should write the smallest tablet quantity consistent with good patient management to
Please see brief summaty
of prescribing information
on adjacent page.
every 4 to 7 days
COMPULSIONS
reduce
overdose risk.
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of Charles
University,
KeKarlovu
11,12821
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2, Czech
Republic; 42-2-29-10-83.
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October
2-5, national
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Ohio.
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Contact
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Long Grove,
Illinois 60047-7676;
550-0090,
fax 708-550-0095.
708-
October
6-8, annualmeeting,
Amencan Academy
of Clinical
Psychiatnists, San Diego. Contact Alice Munoz,
Executive
Director,
AACP,
P.O. Box
3212,San
Diego, Califbrnia92l63;
619298-0538.
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October
6-10,
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sponsored
by the Amencan Psychiatric
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Copley Place, Boston. Contact
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Coordinator,
IPS,
APA, 1400 K Street, N.W., Washington, D.C. 20005;
202-682-6314.
chiatnic
Services
tute
on Hospital
October
1 1-1 3, conference
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contracting,
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and the Institute
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Contact
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Califbrnia 94028; 415-851-8411.
October
ference
sponsored
Addiction
12-15,
eighth
national
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by the American
Society of
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Marriott at Eaton
Centre,
Toronto. Contact Sandy Metcalf,
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Suite 101, Chevy Chase,
Maryland 20815;
301-656-3920,
fax
301-656-3815.
October
York 14607;
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October
management
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6-7, conference
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Psychiatnic
October
integration
tion
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into
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Contact
Conference
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Re-
hyand
Services
16-18,
conference
on the
ofbehavioral
and nelaxa-
(Cantinuedon
September
1995
VoL
page 890)
46
No.9
Because patients
are frightened by their
positive symptoms
-b,--
ii
L
Positive
Delusions
*
Conceptual
disorganization
Hallucinatory
behavior
Symptoms
Blunted affect
*
Emotional withdrawal
*
Poor rapport
*
*
*
Excitement
*
Passive!apathetic social
withdrawal
Difficulty in abstract
Grandiosity
*
thinking
*
*
Lack of spontaneity and
flow of conversation
*
*
Stereotyped thinking
*
Suspiciousness!
persecution
Hostility
*
improved significantly within group from
* p<O.05,
baseline. Within group companson ofschizophrenic
patients receiving risperidone
6mg/day
in North
American clinical
trial (n=513).
The Positive and NegativeSyndrome Scale (PANSS) in
its entirety also includes 16 general psychopathology
score items; therefore, condusions
comes of individual items should
#{149}
Information
brief summary of Prescribing
adjacent to this ad.
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JPl-RS-123A
3SrntthKIrn
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A first choice in psychosis.
r
A first choice in psychosis.
RISPERDAL
(R)T
8sfo($
ptSicrIbin
consult compises prwcflbln9 Information of
INch thsfo1IowIn isa biW summary.
lOCATIONS *NUSAGE:
RISPERDAL’
dicaIed for the management of
the manlestations 01 psych* csoniers.
CONTRAINDICAT1ONS: RISPERDAL is contraindicatod
in patients wfh a
;4ren8tMtYtoe*uc1
Srome
(NMS) has
repoflsd m eociion
ofth wd*ychofE ugi f a
_of
req
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re#{241}rockiofon
of chug therapy iodd becekyalnsidBte
The perf thoiAd be
carikfmonore
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TM
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dysidnedc movements may
devek#{231}
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treated ofth aofipsych* d,u
Mhoi4 the prevalence of
the syndrome appears to be highest among the eldedy, especially elderly
women, ft e dlleto
rely iqton prevelen estimalee
ptecIc at the bcep.
of
bpeh
treatment,
ients
are ely to develop the syp&om!.
ft s9s wd syn#{231}lome
of loratve dyeloneela oppeer lo a patlent on RlSPERDAL ,
doug dlecontinuation should be
However, some patents may requtre
treatment wIth RISPERDAL’deepllethe
preeenon of the syndrome.
Potential for Proarrhythmlc Effects: Risperidone and/or 9.hydroxy.
rlepeddone appears to lenhen the 01 tmeivel to enom patlerd eltho4 there
to no avere iieaea
to treated patler* even at 12-16 mday, mel elme the
recommended does. Other drugs that prolong the 01 litervel have been aseoci.
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bnbalwice, ooncomtlwrt use mith ar
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long 01, or the presenon of congenitatprolongationto 01 cen rncreasethe dab
loroccurrence of thisarrhythmia
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RISPERDAL may loduce orthostattr hynolension
associated with rtlzziness, tachycarctla, and m some patients, syncope, especially
rhihng the Mel deee.btratlon perio probably reflecting to &pha.adrenerglo
wtstlo
pro.
The dab of odhoetatlohvpotensionend syncope may be
minimized by totting the betel dose to 1 mo thb to normal acbdts arid 0.5 mg
BO to the elderly and patents wWi renal ohepatlo bopeinnent (See DOSAGE
AND ADMINISThATIQN). A dose redriction shorid be considered ll hypolenslon
occu
RISPERDAL should be used dath pardcutar caubon to patients with
known carditovascular ditseese (hietmy of myocarolalbdaidtlonor iacheml trend
taljre, or condriction abnormalltlee), cerebrovascular dleease, and conditions
which would predispose petleritsto hypotenslon(dehy&ation,
hypovolemi end
tresbnentwth amihonerlenshe medlowions).
Selans: RISPEROALC
be used caitiousty to patients with a tdsloiy of
Iy*jwulecabremia
As atm other drugs that entagonize dopemtoe 0, recapto(
elevates proleoth levels and the elevation persiats dadng cirronto administration. Tissue culture experiments todicale that approximately one
third of hooverbreastcascara are prolecdadependent to vitro, a factor of pollenhal tropottance it the preecrrtlon of these drugs le coritensylaled to a patient with
previously detected breast cancer. As is common with compounds which
kicrease prohmto release, an tocreese to pitultreywr
mammrey
end
pencreatic lobe cell hyperplasia endfor neoplasiawas observed to the Isperidone
carcinogenicity studi conducted to mice and rats (See CARCtP4OGENESIS).
However, neither clinical studies nor epidemiologic studies conrhicted to date
have shown en association between chronic athninistrabon of the class of drugs
and Wmodeneele to tunw
the avalable evidence a considered too Nmitedto
be concluerveat thistime.
jn
coqualv. aidMo
hiiituient
Somnolence was a commonly
reported and dOee.related adverse event associated with RtSPERDAL’treatmint. Shins RISPERDAL has the potential to vnparr iudqurent, thlnldng, or
motor sioll patiente shoofd be cadioned abord operating hazardous mechiorey,
aAomoblle
onalltheywecaflatothatRlSPERDk#{149}therspy
does not alterdthem adversely.
Rarecases of prm have been mporte
A single case of lIP was reported
a 28-year.old female patient receiving
RISPERDALTh
relationshto
RISPERDAL therapy is imimoren.
Rieperidone has en aitlematic elect to enimals this elleci may also coot to
human and may mask slew and synitoms of oventoeage withcertaindrugsor
of conathonssuch as toteelinalobstruction,ReyO syndrome,end brwhtumor.
CaLdion is advised when ecrtlng
for patients who will be expoeed toteiquer.
The ooeelbllltv of asuicldsatteropt
is inherent to echeophrerda and dose squervision of hig#{241}
risk patients should accorreranydrug therapy. Prescr$,llons for
RISPERDAL’shOUId be wrItten forthe smalleet quantity oftablets coneisteniwith
good patient management, to orderto reducethe rbeOlOVerdOee.
Ollnical experience with RISPERDAL’ to patientswithcerteinconcomilawi aye
testis iaeaee
is toilet Catitlon is advisable to patientswith Iseasee orcondevon that owed eflect metabolism or hemodynarnic meponsea Because of the
rieks of orthoetatic hypotension end 01 prolongator caraton shorid be observed
to cardiac patlento (See WARNINGS end PRECAUTIONS).
In patients with severe renal kr#{231}airmenl
(creathrine clearance <30 mLknl&1.13
is#{176}),
orwith severe hepatlo tonerit,
a towerstarting dose should be uset
Patients should be advised ci the risk of oithoetahchypotension,especially diiimg theed
of initialdose titration.
Patients should be cautioned about operating hazardous machinery, todudtog
automoblle seat they are reasonably certain that SPERDAL
therapy does
not elect them adversely. Tell patients to nasty drab plrysicien it they become
pregnant or intend to become pregnant durIng therap not to breast feed an
itsient to tofomr their phis
it they are taldn or plea to tabe, any prescr,
floe or over-the.counterdrug
to avoid alcohol.
No specific hmoratoryteats are recommendet
The ivteractions of RISPERDAL and other drugs have not been systematically
evaluated. Caiduon strand be used when taken to combination with othercerfral
acitngdmgsendalcohcd.
RISPERDAL’may enfsecathe hysolensive ellecisofdeartheispeislcagentewith
ftdopolerdial arid itmayaritaponicethe ettectsofisvodopaanddcpenrtoeagordsta
chronic administration of cwhamazepine- or clozapise with risperidone may
mcrease theclearance of risperidone.
Riaperidone is metabolized by cytoctwome PseIID an enzynre thatcan be tohibfed r a variety of psychotropicand other drugs. Analysis of clinical studies
involving a modest numnber of poor metabolizers (niD) does not suggest that
poor and eotensive metabolizershave dIfferent rates of adverse effeols No cornS
parson of effectiveness to the two groups has been made. In vitrostudies
showed that drugs metabolized by other es iaozymes are only weak tohthliors
of deperidonemetabolism.
In vitro studies indicate that risperldone is a relatively weak inhibitor of
cytochiome PIID
and is not expected to substantially tohbt the clearance of
drugs that are metabolized by this enzymatic pathway. However, clinical data to
combo this on
am not avaffalile.
Carcinogenicity studies were conducted to Swiss albino mice and Wistar rats
Risperickine was administered tothe dietat doses of O, 5, and 10 mglkgfor
l8mordhstomiceandfor25morfhstorata
TheeedoeesamequlvalenttoZ4,
9.4 arid 37.5 lenes the madmum human dose (16 mgfday)on a mgfogbasis or
02, 0.75 and 3 daresthe maidmumteimen dose (mice) or 04, 1. and 6 times
the maidmum human does (rats) on a mglm2 basis. There were statistically alp
reticent increases to pituitary
adenomas, endocrine pancreas adenomas
and manimary
adenocarclnom
These neoplaams are considered to be
ptolactln.mediatet
The relevance for human risk of the findings of prolactln.
medIated endocrinetumors in rodents is unknown.
No esidence of mifagenic polentlal for risperldone was loud
Risperidone (0.16 to 5 mofig) was shown to bopairmatIn but not fertility,to
easter rats to three reproduobvestudies at doses 0.1 to 3 tInes the maidmum
recommended human does on a mm2 basis. The effect appeared to be in
females
a aidchronlc study to Beaa dogs, sperm motilityand concentration
were decreased at obese 0.6 to 10 flares the human dose on a rngfrol basis
Dose-related decmasee were also noted In serum testosterone at the same
doses. Serum testosterone and sperm parameters partially recovered but
remained decreased after treatment was discontinued No on-Sleet doses were
riolad to eitherratordo
Pregeency Cataaory C: The teratogenic potential of riapeildone was studied to
Sprague.Dawley enciWistar rate end to New Zealand rabbits The incIdenceof
mallomiatlons was net increased con#{231}amd
to control to offspring of rate or rab
bits ven 0.4 to 6 tinree the human dose on a mghnh basis to three repnoducilve
strides to rats there . en increaseto popdeabreduringthe host4 days of lao
talionatdoeeaO.1
to3bmeethehumandoseonamgfm’baslaftisnotknown
whether these deaths were titie to a direct effect on the fetuses or piw or to
effects on the dress There was no noiffecti doeefor increased rat pup mortality.
in one Segment IIIstudy, therewaaan increase in wilbom ratpr#{231}e
atadoae 15
times tiwthan
the human doeeon a mgtrn#{176}besis.
Placental transfer of dadone
occurs to ratpope. Thereare no adequ and
weLcontnouled studies to pregeent women. However,there was one reportof a
case of aganesis of the corpus ndhosum to ge wisedeopoeed to riaparidone to
utem. Thecauaal relwionahlyto RISPERDAI. therapy is imimorert
RISPERDAL’ ahorid be reed turing pregnancy ontyif the potential benefit justiflesthe potential rialitothe fetus
The effeclon taliorend delivery to humansis unknown
it is not known whether or net riapeddone is excreted to human mflk In animal
studies, dapeddone and 9.hvdnoxvrlaoerldone were excreted in breast mi$
Therefore, women receiving RISPEADAL5h0utd net breasiteet
Safety and effectiveness tochildrenhave not been established.
clinical studies did not include sidhcierl numbers of patients aged 65 and over
todslsmiinewhetherthey
reeponddlhrentlyfmmynungerpatlents
in general,
a tower starting dose is recommended for an elderly patient, reflecting a
decreased noaooldnetIc
clearance to the elderly, as well as a greater fre
ciency of decreased hspatic, ren or cardiac tuncdo and a greater tendency
to postural hypolenaion (See WNICAI. PHARMACOLOGY and DOSAGE AND
ADMINISTRA
Msoclatad reith DIscontinuatIon OlTisatsessit
*4ma5ely
9% psrcard(244Pa17)
of RISPERDAL’treated patlenta to phase
2-3 studies discontinued treatment due to an adverse event, conspired with
about 7% on placebo and 10% on active control drugs. The more common
avails ( O3%)asaociated with discontinuation and considered to be poasthty or
dm
odet
aidrepysamide sytom
dunee
hypadane
re somnolence, and nausea
Sricithal5wseaseociated*discor*uuimr
to 12%of RISPERDAL4eatad
patients compared to 0.6% of placebo patients, brti given the almost 40.fold
iseater erqoeum tow to RISPERiAL#{149}compamd
to placebo paterd I is wfkaly
thatauicideatheir#{231}tisaRlSPERiAL’islatedaiMrseevei1(See
PRECAUTIONS).
kicidenos lii COIfIOIhdTrIalS
IIa,wevsdAdveree
Et*ife hr r*md
ON*ef Tl
Intwo 6.
to 8-weak placebocoilrolsd
trIal spontaneoualy.reporIe
treatmer*emergant
adverse events with an incidence of 5% or greater in at least one of the
RISPERDAL’ gnOI4lS and at least twice that of placebo were: anidety, semen.
:=r
&rnwnL on,
nause
Etched adverse evertis toone oftheaetwotriala present at at least 5% andtwice
the rate of bo
were: increased dream activity, increased duration of sleep,
aocommodaton datuibenca
reduced ndlvatlor mictuditon diatuthence
dis
the walf gal men
diminished mmmi deire, wecate dystu
patients, butwere seen in patients recewing haloparidol (3/126).
Other Events Observed
DurIng the Pre-Mark.tlng
Evaluation
of
RISPERDAL#{149}
Durin9 its premsrketlng assessment, multiple doses of RISPERDAL’ were
administered to 27 patients to phase 2 and 3 studies and the following sean.
dons were reported: (Note ‘trequenr are those occurring in at least 1/100
pients, ‘k*equenf’ we those occurring to 1/100 to 1/1000 patIents, rwe are
thoes occurring to fewer than 1/1000 patients. ft is toiportwrt to emphasize that,
allhouphtheevents
repoitedoccurred duringfreatmeniwith RiSPERDAL, they
were not necesaariy caused by L Paynhiafifc .er#{224}rec Frequent increased
dream actMty, diminished sexual daalre, nervousness. Infrequent bnpalred
de
apathy,
increased Rado,
amneelt Rare: ernotloiwi lebdity, rfgfdmares, daltmm withdrawal syndrome,
yawning. Central and Peripheral Nervous System Disorders: Frequent
kicreased sleep dimition’. infrequent dywth
vent
absy pemeatheei
Outro-Intulinal
Disorders: Frequent: anorexia, reduced salivation’.
M_
flatulence, diwth.s, ased
ep
etomattes, malens, gla, hemOrrhOids, gaatrttis. Rare: focal Incontinence, eructation, gastroesc
re&
tholelthbai
tongue edema, diverticulitia, gingivitis, dIscOlOred feces, GI hemorrhage,
hematemeals.
Body as a WholWOeneral
Dlaorderi: Frequent: fatigue.
Infrequent edema, rigors, malaise, inftuenza.Iike ymphm.
Raric pallor,
-
-
*
seom
bu
Ddeor* in
hyon,
bronchospasm,
atridor. Rare: asthma, increased sputum, aspiration. Skin and
Ofaoi*:
Frequent increased pigmentation’, photoeenslthoty’.
nfmqu.nt
harassed oweOl
score, decreased oweab
alopecis, hynedreratods, pru
his, dun e,ddtaliort Rarabulous en4stor dun udosration, aggravated paodaals,
turunculosis, vernuca, dermatitis lichenold, hypertrichosis, genital pnurltua,
urticarla arthoneouder
Dfeordsrs: Infrequent: palptiation, hypertension,
hypotenalon, AVbtOck, rnyocardialkdatttuon. Ram:venthniartwirycardia,
wt.
his pectoris, premature sInai contractions, T wave Inversions, ventricular
extraes,
STdep
myocardife. Vcnorderac
Wseqismeabnon
malemommodatuoialmia
Ranccdopls,eyepals,
hiepharllls,phctop.
als, photophobis, abnomial lacrimation. Ra
and M*lionef
ordeno
in_
_is,
creatine phosphoNoase increase,
thk wef decrease, diabetse meflk Rererdeomased sense im cachexis,
-
in_
to_
he
dysoda Rear
urinary retention, cystftia, renal Insufficiency. Muaculo-akeletal
System
Odeerrs
in
a
Rear wthme
hmsths, wths,
SkIIetsl pain. ReproductIve
Disorders, Female: Frequent menorrhagis’,
or_
on’,
dry vagina’. Th*wurent nonpuerperal lactetlon, amenorrhos, female breast pa belorthes, mawitis, dysmenonhes, female pedneal
pals, hmnnenstmal buedina vadnal hemorrhage. UaWandRa,y
System
h*equert increased SOOT, increased SGPT. Rare: hepatic falhire,
choicetatic he
th
thoWithhms, henab
daav
ass
anJaowitoieer*r&
inhquentepimaxis,
puxpia
Rere: hemorrhage, aupedlcim phlebitis, thrombophiebats, thrombocytopenla
Rearing and Vesflbuiar D#aors:
Rare: tlnnitus, hyperacusis, decreased
headn
OdCmbFL
Th*equent anemj hyothnomic imma
Rear normocytic anemia Rspreducthw somb
flk
ftequentr erecate
dysfunction’. Infrequent: ejaculation failure. White Call and Resistance
DIsorders: Rare: leukocytosis, tymphadenopathy,
leucopeoda, Pelger.Huet
anomaly. Endecodm savdvac
Rear synecomastis, male hmaat
uredo homronedisorder. wnadSenNec
Raarhitlertaata
‘ incidence baaedon etched reports
PbeabWothsc
Adverse
events reported since madad intro.
duction which were temporally (but not necessarily causally) related to
RISPERDAL#{149}
therapy, Include the following: anaphylactic
reaction,
an
sinS Raation,
cembrovascuho
diseess, diabetas molten
aggravated, hypothermia, Intestinal obstruction, jaundice, mania,
Paddnaon’s disease aggravated, putmonary embolism, sudden death.
ABAtloEFENDcE
ccsifroflid Sishstanc. Sass: RISPERDAL’is not a controlled substance.
Patients should be evaluated carefully for a history of druq,abuse and such
_lda
alholdd be observed closely for ai9ns of RISPERDAL misuse or abuse
-‘.
Ltesadhi
RISPERDAL’(rlspeddone)ahould
be administered on a BID
achedi* gener$ybSgInnIngwIIh
1 rag BID initially,with increases inincrementa
ofl mpBIDonthesecoretwetterddey,estmeratedMatargatdoeeof3mg
BID by the third day. In some patients, slower titration may be medically
The following adverse events occurred at an tocidance of 1% or more, and were
appropriate. FUrtherdOsagea4ustments,
tindicata
ahorid generally occurat
at least as frequent 1001W RISPERDAL4TeaIed patlente treated at doses of
intervais of not less than 1 wee since steady state for the active metabolite
10 mgfday then bong botreated
patients to the pooled results oftwo 6. to
would not be achieved for approximately I week in the typical patient. When
8-week controlled hith. Paychl*Ic
Oleorderer insomnia, agitation, anxiety,
dosage 4ustments
are necessary, small dose increments/decrements of I rag
eo
reashe
se
Nemoun *ac
aidiopyTaoldaleyswlonw’,
BID are recommended.
Mtloahoficefffcacywasdemonetrated
toadoee ranaeof4to lemg/daytothe
deneea
*ao
conenkon,
mewn
al vomlitoabdonmnalpalraMtoothactre.
Raspisiorysyatamo
clinicaltrials atqiportmg effectiveness of RISPERDAL however, maximal effect
nitoiti cou*
alnual
dyspnea Body as aWholai beck pain, was generally seen to a range of 4 to 6 mg/day. Doses above6 mgkiaywere not
cheat palaver.
Ds,miolof$cal
rash dry skin, sebonhet Wectlonai u#{231}perdemonstrated to be more efficacious than lower doses, were associated with
respiratory.
Visual: abnormal vision. Nuaculo.$kslital:
arthralgia.
more eithapy,arnidal symptoms and other adverse effects, and we not generally
ovascelar.taa
recommended. The safely of doses above 16 mg/day has not been evakiated to
I Includes
tremor, dystonia, hypokinesia, hypertonia, hyperkinesia, ocuto.
clinical trials 001*
hr SpecteIipsdedemo
The recommended filial dose is
gyric crisis, ataxia, abnormal gait, involuntary muscle contractions,
0.5 m9 BID to patients who are elderly ordeblfftate patientswlth eavere renal or
hyporeflexia, and extrapyramidal disorders. Although the Incidence of
knnt,
andeitheriaposedtohyon
orforwhom
‘extrapyramidal synsytoms does not appear to differ for the ‘ 10 mgIdaV hyjiotenalon worM pose a risk. Dosage increases to these patientsshonidbe to
BID. increasastodosagesabove
1.5mgBlD
eons and placebo, the data for individual dose groups in fixed dose triala incrementsofno morethano.5mg
shoutd generally occur at intervals of at least 1 week In some patients, slower
responae
relationship (See OOSb DEPENDENCY OF
titrabon may be medically appropriate.
DowaDspaIdenqOlAthWWEvVIfe
Datatrom twofuxed dosebsis provided
Elderly or debilitated patients, andjwhents with renal bnpalnnent may have less
evidence of doaerelatedness
for extrepyramidal symptoms associated with ability to eliminate RISPERDAL than normal aduits. Patients with impaired
done
treaboert Adverse event data elicited by a cheddist for side effects
hepatic function may have increases in the free fraction of the risperidone,
from a large study conng
5 thred doses of RISPERDAL(1, 4, IZ and 16
bly
resulting in an enhanced effect (See CLINICAl. PHARMAGOLOGY)
mgklay) revealed a positive trend for the following adverse everfic sleepiness,
Patientswithapredispoeltlonto
hypotensive reactionsortorwhomsuch
reactions
horeased duration cJ sleep, accommodation distuibences, orthostatic dizziness,
would pose a particular
risk likewise need to be tended cautiouslyand carefrily
monitored(See PRECAUTIONS). Sre*hksgfrom
O1IWAMreysIhO&scThem
are no systematically collected data to specifically address switching from other
viOl sI
asenias:
RISPERDAI. is associated with orthoatatic hypolisnsion
antipsychotics to RISPERDAL, or concerning concomitant administration with
and tachycamia (See PRECAUTIONS).
other antipsychotics.
While immediate discontinuation of the previous
lenpmoThe
proportions of RISPERDAL’ and placebo4eated patients
antipsychotic treatment maybe acceptable for some patients, more gradual
meOlngawalodtedonof7%ofbudyweldwemcoropatedtoapodof
discontinuation may be moat appropriate forother patients. In all cases, the
period of overlapping antlysychodo administration should be minimized. When
6. to8-wealuplacebo.corfmladtrlals,
revealingaafatistlcalty algellicaritty greater
ofwe
sin or
PERDAL (18%) compared to pheebo (9%
switching patients from depot antipsychotics, f medically appropriate, initIate
Labomtmy asengas: A between grcr#{231}
comparIson for 6. to 8-week
RISPERDAL’ therapy in place of the next scheduled injection.The need for
cordinuin9exiMto9jSmedIcationahoutdbereevaluatedPedodoal.
controlled trials resealed no statistically signilicarit RISPERDAL4IIaCSbO differencee in the propodions of patients experiencing potentially toqxxtwd changes to
routine serum chemistry, hematology, or urinalysis parameters Simliady, there
Augnd 199 Deember 1004
were no RISPERDAL’Ij,lacebo dIfferences in the incidence of discominuatlons
for change
in serum chemistry, hematology,
or urinalysis. However,
JANSSEN
..==i..
RiSPERDAI. administration was associated with increases to serum prolactin
(See PRECAUTIONS).
TITUSVILLE,
NJ
08560
ECO Changs: The electrocardiograms
of 8 ouf of 380 patients taking
RISPERDAL whose baseline OTc interval was less than 450 maec were
observed to have QTc intervals greater than 450 isaac during treshnent (see
May1995
Printed in USA
WARNINGS Ohanges of this type were not seen among about 120 placebo
Because a whole
person is waiting
to emerge.
Although the exact mechanism of action is unknown:
#{149}
Improvement of negative symptoms and lessened risk of EPS
are thought to result from blockade of serotonin 5-HT2receptors,
possibly through a
modulatory effect
on dopamine D2
activity in the
frontal cortex
and the basal
ganglia.*
#{149}
Improvement of
positive symptoms
is thought to result
from blockade of
dopamine D2 receptors
in the limbic system*
Dopaminergic
L Lacombe S. Pharmacological
*Ereshefsky
nsperidone.
Can iPsychiatry.
1993;38(Suppl
JANSN
Pharmaceutica
Inc. 1995
#{149}
Serotoninergic
profile of
3):580-588.
‘RISPERIDONE
Please see the bnef summary of Prescribing Information
adjacent to this ad.
©Janssen
system
JPI-RS-123D
Sm,thKu,na
rrurou
Becham
A first choice in psychosis.
system
-
ii
,4;f
VENLAFAX/NE
HCI
A Serotonin
and Norepinephrine
Reuptake
Inhibitor
“Investigations
of the action mechanisms of antidepressants
have provided support for the importance of(serotonin
and norepinephrinej
interactions in the patho physiology
of depression.”
-reported
Pharmacologic
Compound
NE
TCAs2-3
,‘
=
The
Histaminergic
Adrenergic
strong
affinity.
clinical
reuptake
#{149} Like
#
IbIl
norepinephrine;
*Serotonin
Muscarinic
Affinities
‘S
EFFEXOR5
=
Receptor
5HT
SSRIs4
NE
activity
Inhibition
Uptake
in Kalus et al
5HT
significance
inhibition
SSRIs
#{149} As with
=
tricyclic
among
SSRI
antidepressant;
of these in vitro data
varies
and TCAs,
SSRIs,
TCA
serotonin;
=
=
selective
serotonin
reuptake
inhibitor.
is unknown.
TCAs.
EFFEXOR
anticholinergic-like
is a weak
inhibitor
side effects
#{149} EFFEXOR
is a structurally
novel antidepressant,
to any other
available
antidepressant5
may
of dopamine
occur
and
with
is chemically
reuptake
EFFEXOR
unrelated
EXPAND
YOUR
TREATMENT
POSSIBILITIES
An
effective
firstIine
depressed
therapy
for
patients
Response
in depressed
outpatients’
100%
#{149}EFFEXOR n39
.
o75%.2
Imipramine
n
U Placebo
a
n
=
33
47
0.2
co:
50%-
U
25%C
U
0%
Baseline
I
2
3
Time
No significant
Significant
*Response
2 (much
difference
between
4
6
(weeks)
EFFEXOR
and imipramine
was observed.
difference
(P < 0.05); venlafaxine
and imipramine
> placebo at week 6.
to treatment
was defined as CGI improvement
score of I (very much improved)
or
improved).
In one randomized,
on venlafaxine
double-blind,
or imipramine
placebo-controlled
study of depressed
at 75 mg to 225 mg daily in divided
The effectiveness
of EFFEXOR
in long-term
cally evaluated in controlled
trials.
patients
doses (observed
use (>6 weeks)
initiated/maintained
cases at week
6).’
has not been systemati-
EFFEXOR
is contraindicated
in patients tsking monoamine
oxidase inhibitors
(MAOIs). EFFEXOR
should not be used in combination
with an MAOI or within at Iest 14 days of discontinuing
treatment with an MAOI because of potential
for serious adverse reactions.
Based on the half-life of
EFFEXOR,
at least
7
days should
be allOWed
after
stopping
EFFEXOR
before
starting
an
MAOI.
Treatment
with EFFEXOR
is associated with sustained increases in blood pressure (BP) in some patients.
These appear to be dose dependent
and were seen at an incidence of >5% at dosages above 200
mg/day.
Regular monitoring
of BP is recommended.
As with any psychotropic
drug, EFFEXOR
may impair judgment, thinking, or motor skills, and patients
should
be advised
to exercise
caution
until they have adapted
The most common adverse events reported
in EFFEXOR
placebo) were: nausea, somnolence, dry mouth, dizziness,
abnormal ejaculation/orgasm,
and anorexia.5
Please
see brief summary
of prescribing
information
to therapy.
clinical trials (incidence > I 0% and
2x that of
constipation,
nervousness,
sweating, asthenia,
on last page of this advertisement.
HCI
VENLAFAX/NE
25
Adverse Events Occurring atan Incidence of 1% or More Among Effexor-Treated Patients:The following occurred in 4- to 8- week placebo-controlled trials, with doses of 75 to 375 mg/day, at a
frequency of 1% or more. This includes patients with at least one episode ofan eventat some time
during treatment. Body as a Whole: headache, asthenia, infection, chills, chest pain, trauma,
Cardiovascular: vasodllatation, increased blood pressure/ hypertension, tachycardia, postural
hypotension. Dermatologlcal: sweating, rash, pruritus. GastroIntestInal: nausea, constipatIon,
anorexia, diarrhea, vomiting, dyspepsia, flatulence. MetabolIc: weight loss. Nervous System:
somnolence, dry mouth, dizziness, insomnia, nervousness, anxiety, tremor, abnormal dreams,
hypertonia, paresthesia, libido decreased, agitation, confusion, thinking abnormal, depersonalization, depression, urinary retention, twitching. Respiration: yawn. SpecIal Senses: blurred vision,
taste perversion, tinnitus, mydriasis. Urogenital System: abnormal ejaculation/orgasm, impo-
mg, 37.5 mg, SO mg, 75 mg, and 100 mg
Brief Summary
See package Insert for full prescribing Information.
ClInIcal Pharmacolouy: The antidepressant
action of venlafaxine
is believed to be associated with
potentiation of neurotransmitter activity in the CNS. In preclinical studies, venlafaxine and its
active metabolite, 0-desmethylvenlafaxine (ODV), were potent inhibitors of neuronal serotonin and
norepinephnne reuptake and weak inhibitors of dopamine reuptake.Venlafaxine and ODV have no
significant affinity for muscarinic, histaminergic,
or a-i
adrenergic receptors in vitro.
Pharmacologic activity at these receptors is hypothesized to be associated with the various anticholinergic, sedative, and cardiovascular eftects seen with other psychotropic drugs. Venlafaxine
and ODV do not possess monoamine oxidase (MAO) inhibitory activity.
Indications and Usage: Effexor is indicated for the treatment of depression.
Contrslndlcatlons: Contraindicated in patients with known hypersensitivity. Concomitant use in
Datients takina monoamine
oxidase inhibitors (MAOIs)
is contraindicated
(see “WarnIngs”).
Warnings: POTENTIAL FOR INTERACTIONWITH MONOAMINE OXIDASE INHIBITORS (MAOIs)Adverse reactions, some serIous, have been reported when venlafazlne therapy is inItIated
soon after dIscontInuation of an MAOI and when an 00*01 Is InItiated soon after dIscontInuetion of venlafaxine. Reactions have included tremor, myoclonus, dlaphoresis, nausea, vomlt#{149}
ing, flushIng, dIzzIness,
hyperthermla wIth features resemblIng neuroleptic malIgnant syndrome, seizures, and death. Given these reactions as well as the serious, sometimes fatal
Interactions reported wIth concomItant or immediately consecutIve admInIstratIon of MAOIs
and other antidepressants with pharmacological propertIes simIlar to Eftezor, do not use
Eftexorin combination wIth an MAOIor wIthIn at least 14 days of discontInuIng 00*01 treatment.
Allow at least 7 days after stoppIng Effexor before starting an MAOI. Hyperthermia, rigidity,
myoclonus, autonomic instabIlIty, mental status changes including extreme agItatIon progreasing to delIrIum and coma, and features resemblIng neuroleptic malignant syndrome have
been reported wIth concomItant selective serotonln reuptake lnhlbltorIMAOl therapy. Severe
hyperthermla and seizures, sometimes fatal, have been reported with concomitant trlcycllc
antldepreuants/MAOI
therapy.
SUSTAINED HYPERTENSION-Effexor
treatment is associated with dose-related sustained
increases in supine diastolic blood pressure. Regular monitoring of blood pressure is recommended, and, when appropriate, consider dose reduction or discontinuation.
PrecautIons: GENERAL-Anxiety
and Insomnia: Anxiety, nervousness, and insomnia have been
reported in short-term studies.
Changes in Appetite.’Weight: Anorexia has been reported in short-term studies, and a dose-depen-
dent weight loss has been reported in patients takinQ Effexor for several weeks.
Activation of Mania,/Hypomania: Hypomania or mania has been reported; as with all antidepressants, use cautiously in patients with a history of mania.
Seizures: Seizures were reported in premarketing testing (0.26%). Use cautiously in patients with
a history of seizures. Discontinue it in any patient who develops seizures.
Suicide: The possibility of suicide attempt is inherent in depression and may persist until significant remission occurs. Closely supervise high-risk patients during initial drug therapy. Write
Eftexor prescriptions for the smallest quantity consistent with good patient managementto reduce
risk of overdose.
Use in Patients with Concomitant Illness: Clinical experience with Eftexor in patients with concomitant systemic illness is limited. Use cautiously in patients with diseases or conditions that
could affect metabolism or hemodynamic responses. In patients with renal impairment (GFR=1O7OmL/min) or liver cirrhosis, clearance of venlafaxine and its active metabolite were decreased,
resulting in prolonged elimination half-lives. A lower dose may be necessary: use with caution in
such patients.
INFORMATIONFORPATIENTS-Clinical studies revealedno clinicallysignificantimpairment of psychomotor, cognitive, or complex behavior performance. However, caution patients about operating
hazardous machinery, including automobiles, until they are reasonably sure that Effexor does not
adversely affect their ability to engage in such activities. Tell patients to 1 ) notify their physicianif
they become pregnantor intendto become pregnantduring therapy,or if they are nursing;2) inform
physicians about other medications they are taking or plan to take; 3) avoid alcohol while taking
Effexor; 4) notify their physicians if they develop a rash, hives, or related allergic phenomena.
DRUG INTERACTIONS-Cimetidine: Use caution when administering Effexor with cimetidine to
patients with pre-existing hypertension or hepatic dysfunction, and the elderly. Drugs Inhibiting
Cytochrome PIID6 Metabolism: In vitro, venlafaxine is metabolized to its active metabolite,
0-desmethylvenlafaxine (ODV), via cytochrome P4,IID,. Therefore drugs inhibiting this isoenzyme
could potentially increase plasma concentrations of venlafaxine and decrease concentrations of
ODV. Drugs Metabolized by Cytochrome PIID,:
In vitro, venlafaxine is a relatively weak inhibitor
of this isoenzyme; clinical significance is unknown. Monoamine Dxidase Inhibitors: See
“Contralndlcations
and Warnings. CNS-Active Drugs: Use of venlafaxine with CNS-active
drugs has not been systematically evaluated; therefore, use caution when administering Effexor
with such drugs.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITV-Carcinogenesis:
In 18-month
studies, there was no evidence of carcinogenicity in mice given 120mg/kg/day [16 times the maximum recommended human dose (MRHD)J. In 24-month studies, there was no evidence of carcinogenicity in rats given 120mg/kg/day. Mutagenicity: In male rats receiving 200 times (on a
mg/kq basis) the MRHD, chromosomal aberrations were found in the bone marrow in vivo.
Impairment ofFertility: No impaired reproductivefunction was found in rats given 8 times (mg/kg)
the MRHD.
PREGNANCY-Teratogenic
Effects-Pregnancy
Category C. Reproduction studies in rats given 11
times, and rabbits given 12 times the MRHD (on a mg/kg basis) revealed no malformations of offspring. However, in rats given 10 times the MRHD, there was a decrease in pup weight, increase
in stillborn pups, and an increase in pup deaths during the first 5 days of lactation when dosing
began during pregnancy and continued until weaning. There are no adequate and well-controlled
studies in pregnant women; use Effexor during pregnancy only if clearly needed.
LABOR, DELIVERY, NURSING-The
effect on labor and delivery in humans is unknown. It is also
not known whether Effexor or its metabolites are excreted in human milk; exercise caution when
administering to a nursing woman.
PEDIATRIC USE-Safety and effectiveness in children (<18 years) have not been established.
GERIATRIC USE-In clinical trials, 12% of Effexor-treatedpatients were 65 years of age. Overall
differences in efficacy or safety in the elderly have not been demonstrated, however, greater sensitivity of older patients should not be ruled out.
Adverse ReactIons: ASSOCIATED WITH DISCONTINUATION OF TREATMENT-Nineteen
percent
(537/2897) of Effexor patients in clinical trials discontinued treatment due to an adverse event. The
more common events (1% associated with discontinuation and considered to be drug-related
included: somnolence, insomnia, dizziness, nervousness, dry mouth, anxiety, nausea, abnormal
ejaculation (male), headache, asthenia, and sweating.
INCIDENCE IN CONTROLLED TRIALS-Commonly
Observed Adverse Events in Controlled
Clinical Trials: The most commonly observed adverse events associated with the use of Effexor
incidence of 5% or greater and incidence for Effexor at least twice that for placebo): asthenia
tence, urinary frequency, urination impaired, orgasm disturbance, menstrual disorder.
Studies indicate a dose dependency for some ofthe more common adverse events associated with
Effexor use. There also was evidence of adaptation to some adverse events with continued Effexor
therapy over a 6-week period.
Vital Sign Changes: In clinical trials, Effexor was associated with a mean increase in pulse rate of
about 3 beats/mm, and a dose-dependent increase in mean diastolic blood pressure of 0.7 to
2.5 mmHg.
Laboratory Changes: During clinical trials, only serum cholesterol exhibited statisticallysignificant
differences from placebo (increases of 3 rng/dL from baseline); clinical significance is unknown.
ECG Changes: Only heart rate exhibited a statisticallysignificant difference, with mean increases
of 4 beats per minute from baseline.
OTHER EVENTS OBSERVED DURING THE PREMARKETING EVALUATION OF EFFEXOR-Durlng
premarketing assessment, multiple doses of Effexorwere administered to 2,181 patients, and the
following adverse events were reported. Note: “frequent’ = events occurring in at least 1/100
patients; Infrequent”
= 1/100 to 1/1000 patients; “rare’ = less than 1/1000 patients.
Events are
classified within body system categories and enumerated In order of decreasing frequency using
the definitions above. It is important to emphasize that although the events occurred during
Effexor treatment, they were not necessarilycaused by it.
Body as a Whole - Frequent accidental injury, malaise, neck pain; Infrequent: abdomen enlarped,
allergic reaction, cyst, face edema, generalized edema, hangover effect, hernia, intentional injury,
moniliasis, neck rigidity, overdose, chest pain substernal, pelvic pain, photosensitivity reaction,
suicide attempt; Rare: appendicitis, body odor, carcinoma, cellulitis, halitosis, ulcer, withdrawal
syndrome. CardIovascular system - Frequent: migraine; Infrequent: angina pectoris, extrasystoles, hypotension, peripheral vascular disorder (mainly cold feet and/or cold hands), syncope,
thrombophlebitis;
Rare: arrhythmia,
first-degree
atrioventricular block, bradycardia, bundle
branch block, mitral valve disorder, mucocutaneous hemorrhage, sinus bradycardia, varicose
vein. DiUestlve system - Frequent dysphagia, eructation; Infrequent colitis, tongue edema,
esophagitis, gastntis, gastroententis, gingivitis, glossitls, rectal hemorrha9e, hemorrhoids,
melena, stomatitis, stomach ulcer, mouth ulceration; Rare: cheilitis, cholecystitis, cholelithiasis,
hematemesis, gum hemorrhage, hepatitis, ileitis, jaundice, oral moniliasis, Intestinal obstruction,
proctitis, increased salivation, soft stools, tongue discoloration, esophageal ulcer, peptic ulcer
syndrome. EndocrIne system - Rare: goiter, hyperthyroidism, hypothyroidism. Hemlc and lymphatic system - Frequent
ecchymosis; Infrequent anemia, leukocytosis, leukopenla, lymphadenopathy, Iymphocytosis, thrombocythemia, thrombocytopenia, WBC abnormal; Rare:
basophilia, cyanosis, eosinophilia, erythrocytes abnormal. MetabolIc and nutrItIonal - Frequent
peripheral edema, weight gain; Infrequent alkalIne phosphatase Increased, creatlnine increased,
diabetes mellitus, edema, glycosuria, hypercholesteremia, hyperglycemia, hyperlipemia, hyperuricemia, hypoglycemia, hypokalemia, SGOT increased, thirst; Rare: alcohol intolerance, bilirubinemia, BUN increased, gout, hemochromatosis,
hyperkalemia, hyperphosphatemla,
hypoglycemic reaction, hyponatremia, hypophosphatemia, hypoproteinemia, SGPT increased, uremia.
Musculoskeletal
system - Infrequent arthritis, arthrosis, bone pain, bone spurs, bursitis, joint
disorder, myasthenia, tenosynovitis; Rare: osteoporosis. Nervous system - Frequent emotional
lability, tnsmus, vertigo; Infrequent apathy, ataxia, circumoral paresthesia, CNS stimulation,
euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia,hypertonla, hypotonia, incoordination, libido increased, myoclonus, neuralgia, neuropathy, paranoid reaction, psychosis, psychotic
depression, sleep disturbance, abnormal speech, stupor, torticollis; Rare: akathisia, akinesia, alcohol abuse, aphasia, bradykinesia, cerebrovascular accident, loss of consciousness, delusions,
dementia, dystonia, hypokinesia, neuritis, nystagmus, reflexes increased. RespIratory system Frequent bronchitis, dyspnea; Infrequent asthma, chest congestion, epistaxis, hyperventilation,
laryn9ismus, laryngitis, pneumonia, voice alteration; Rare: atelectasis, hemoptysis, hypoxia,
pleurisy,pulmonary embolus, sleep apnea, sputum increased. SkIn and appendages - Infrequent
acne, alopecia, brittle nails, contact dermatitis, dry skin, herpes simplex, herpes zoster, maculopapular rash, urticaria; Rare: skin atrophy, exfoliative dermatitis, fungal dermatitis, lichenoid dermatitis, hair discoloration, eczema, furunculosis, hirsutism, skin hypertrophy, leukoderma, psoriasis, pustular rash, vesiculobullous rash. SpecIal senses - Frequent abnormal vision, ear pain;
Infrequent cataract, conjunctivitis, corneal lesion, diplopia, dry eyes, exophthalmos, eye pain, otitis media, parosmia, photophobia, subconjunctival hemorrhage, taste loss, visual field defect;
Rare: blephantis, chromatopsia, conjunctival edema, deafness, glaucoma, hyperacusis, keratitis,
labyrinthitis, miosis, papilledema, decreased pupillary reflex, sclerttis. UrogenItal system Frequent anorgasmia, dysurla, hematuria, metrorrhagia”,
urination Impaired, vaginitis’;
Infrequent albuminuria, amenorrhea”, kidney calculus, cystitis, leukorrhea, menorrha9la’, noctuna, bladder pain, breast pain, kidney pain, polyuna, prostatitis”, pyelonephritis, pyuna, urinary
incontinence, urinary urQency, uterine fibroids enlarged”, uterine hemorrhage”, vaginal hemorrhage”, vaginal moniliasis’; Rare: abortion”, breast engorgement, breast enlargement, calcium
crystalluria, female lactation”, hypomenorrhea#{176},
menopause”, prolonged erection’, uterine
spasm”. (“Based on the number of male or female patients as appropriate.)
Drug Abuse And Dependence: CONTROLLED SUBSTANCE CLASS-Effexor is not a controlled
substance. In a retrospective survey of new events occurring during taper or following discontinuation, the followinq occurred at an incidence of5%, with incidence for Effexor at least twice that
for placebo: asthenia, dizziness, headache, insomnia, nausea, and nervousness. Taper the dose
gradually and monitor the patient. Evaluate patients carefully for history of drug abuse and
observe such patients closely for signs of Effexor misuse or abuse (e.g. development of tolerance,
incrementations of dose, drug-seeking behavior).
Dosage and AdmInIstratIon: The recommended
starting dose is 75mg/day In 2 or 3 divided
doses, taken with food. If needed, dose increments of up to 75mg/day should be made at intervals of no less than 4 days. Maximum recommended dose, for use in severelydepressed patients,
is 375mg/day, in 3 divided doses. When discontinuing Eftexor after more than 1 week of therapy,
the dose should be tapered to minimize the risk of discontinuation symptoms.
SWITCHING PATiENTS TO OR FROM A MONOAMINE OXIDASE INHIBITOR
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with
Effexor. In addition, at least 7 days should be allowed after stopping Effexor before starting
an MAOI (see “Contralndlcations’
and “Warnings’).
Please consuit full prescribing information for detailed dosing instructions.
This brief summary is based on CI 4193-2, issued May 23, 1994.
References: 1 Kalus 0, Asnis GM, van Praag HM. The role of serotonin in depression. Psychiatric
Annals. 1989;19:348-353. 2. Preskorn SH, Burke M. Somatic therapy for major depressive disorder: selection of an antidepressant. J Clin Psychiatry. 1992;53(suppl):5-18.
3. Richelson E.
Synaptic pharmacology of antidepressants: an update. McLean Hosp J. 1988;8:67-88.
4. Physicians’ Desk Reference. 48th ed. Montvale, NJ: Medical Economics Co Inc; 1994;
Prozac’.877-880;
Zoloft:2000-2003;
PaxW”:2267-2270. 5. EFFEXOR prescribing information,
Wyeth-Ayerst Laboratories, Philadelphia, PA. 6. Data on file, Wyeth-Ayerst Laboratories.
12% vs. 6%), sweating (12% vs. 3%), nausea (37% vs. 11%), constipation (15% vs. 7%),
anorexia (11% vs. 2%), vomiting (6% vs. 2%), somnolence (23% vs. 9%), dry mouth (22% vs.
11%), dizziness (19% vs. 7%), nervousness (13% vs. 6%), anxiety (6% vs. 3%), tremor (5% vs.
1%), blurred vision (6% vs. 2%), abnormal ejaculation/orgasm male (12% vs. <1#{176}h),
and male
impotence (6#{176}!.
vs. <1%).
S
0 1994, Wyeth-Ayerst Laboratories
83561
WYETH-AYER&
LABORATORiES
August 1994
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meeting,
of Psychiatrists,
Fukuoka, Japan. Contact Satoshi Tsutsumi, M.D., Secretariat
for the Seventh
Meeting
oIPRCP,
Department
of Psychiatry,
Fukuoka
University
School of
Medicine,
7-45-1
Nanakuma,
Jonankti, Fukuoka
814-01,
Japan;
81-92801-1011, ext. 3385, fax 81-92-8633150.
Pacific
October
24-27,
Rim
College
27-November
2,
annual
Association
of
of Departments
of Psychiatry,
Washington
and Capitol
Hiltons, Washington,
D.C. Contact Fredcrick G. Guggenheim,
M.D., SecretaryTreasurer,
AACDP,
University
of Arkansas Medical
Sciences
Center, 4301
West Markham,
Mail Slot 554, Little
Rock, Arkansas 72205; 501-686-5483.
meeting,
Chairmen
American
October
29-November
2, annual
meeting,
American
Public
Health
Association,
Convention
Center,
San
Diego.
Contact
Convention
Services,
APHA,
1015
15th
Street,
N.W.,
Washington,
D.C. 20005;
202-7895670.
October
29-November
3, seventh
congress
of the International
Psychogeniatnic
Association,
Sheratonon-the-Park
Hotel, Sydney, New South
Wales,
Australia.
Contact
Associate
Professor
Edmond
Chiu, Department
ofPsychiatry,
University
ofMelbourne,
Mont Park Hospital
Campus,
Private
Bag 1 , Rosanna
Victoria
3084,
New
South
Wales,
Australia;
61-3-4560194, &x 61-3-458-2274.
Psychiatric
Services
November
November
Group
chiatry,
White
2-4,
semiannual
meeting,
of Psy-
for the Advancement
Stouffers
Westchester
Hotel,
Plains, New York. Contact Allan
Beigel, M.D., President,
GAP, P.O. Box
28218, Dallas, Texas 75228; 214-3881310, fax 214-381-3509.
November
2-5 , annual
meeting,
American
Association
for Marriage
and
Family
Therapy,
Sheraton
and
Hyatt Hotels,
Baltimore.
Contact Michad
Bowers,
Executive
Director,
AAMFF,
1 100 17th Stteet,N.W., 10th
Floor,
Washington,
D.C. 20036;
202452-0109,
&x 202-223-2329.
November
9-1
1, annual
conference,
Association
for Medical
Education
and
Research
in Substance
Abuse,
Sheraton
City Centre
Hotel,
Washington,
D.C.
Contact Phyllis Arnold, AMERSA,
Brown
University,
Box G-BH,
Providence,
Rhode Island 02912;
401-863-7791,
email [email protected].
November
9-12,
annual
meeting,
Academy
of Psychosomatic
Medicine,
Princess
Marquis
Hotel,
Palm
Springs,
California.
Contact
Evelyne
Halberg,
5824 North
Magnolia,
Chicago, Illinois 60660; 312-784-2025.
November
12-14,
conference
on innovations
in trauma
rehabilitation,
sponsored
by Bethesda
Hospital
and
the Transport
Accident
Commission,
Hilton
on the Park Hotel, Melbourne,
Victoria,
Australia.
Contact DC Conferences, P.O. Box 629, Willoughby, New
South Wales 2068, Australia;
61-2-4396744, fax 61-2-439-2504.
December
December
1-3 , annual
meeting,
American
Academy
of Psychiatrists
in Alcoholism
and Addictions,
Ritz
Carlton
Hotel, Amelia
Island, Florida.
Contact Jeanne G. Trumble, MS.W.,
Executive
Director, AAPAA,
8340 Mission
Rosd,
Suite
66206;
B-4,
Prairie
Village,
Kansas
913-341-6680, fax 913-642-2431.
1 1-1 5, annual
meeting,
American
College
of Neuropsychopharmacology,
Caribe
Hilton,
San
Juan,
Puerto Rico. Contact Oaklye Ray,
Ph.D., Secretary,
AN,
Vanderbilt
University, 1823 Station B, Nashville,
TenDecember
nessee
37235;
615-327-7200,
fx
615-
327-7078.
September
1995
Vol.
46
No.9
0 CD:
A DECADE
SATURDAY,
Marriott,
CHAIRPERSON:
Eric
PRESENTERS:
Michael
The
Psychiatric
Aiiicrican
Education
APA
Recognition
to
sp11sor
clesigililtcs
AsvaI(l
Association
contiluhilig
this
of
continuing
the
(APA)
G, 4th
A.Jenike,
the
M.D.,
is accredited
h)i
nedical
cducation
American
\icdical
Assocation
Supported
l)\ an tticstrictcd
Floor
Lewis
M.D.,John
American
edticatioii
Place
M.D.
Zohar,
k
I11C(liCdl
Salon
Hollander,
1995
A.M.
Copley
Ballroom,
Joseph
The
- 8:30
A.M.
Boston
S/)OflSO?’Pd
7,
OCTOBER
6:30
Grand
OF PROGRESS
H. Greist,
Psychiatric
b’ the
R. Baxter,
M.D.
Association.
(
ACCrC(litatioll
ouncil
for
activity
and
I
for
for
the
c(lUcati()Ilal
credit
IU)LLI5
(\IE
rcqtiirciciit
giaiit
froni
in
1
(atcgorv
of
the
the
Physician’s
Inc.
CoCenss
The Essential
the Dually
Element
of
\PA.
Collaboration:
National
(Mental
Conference
Association
Diagnosed
Illness/Mental
29 November
Radisson
and
.
\Ie(liCdl
Ccuitinuiiig
physicians.
12th Annual
-
M.D.
-
Twin
Retardation)
2 December
Towers
Convention
Hotel
Center,
.
Orlando,
Florida
For a Conference
and/or
call
Brochure
an Exhibitor
or fax Management
Excellence
Phone:
Inc.
513.223.8008
Fax: 513.223.6307
for
Prospectus,
1995
New Frontiers
in Psychiatric
Treatment
and Managed
Care
.
INSTITUTE
11111
.
.
PSYCHIATRIC
SERVICES
OCTOBER 0-ID.
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September 1, 1995
8 Industry-supported
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Breakfast, Lunch and Evening Symposia
some of the key faculty
scheduled to present
Marshal F. Folstein, M.D.
Steven M. Mirin, M.D.
Marshall Forstein, M.D.
Robert T. M. Phillips, M.D.,
Renato D. Alarcon, M.D.
Shervert H. Frazier, M.D.
Anne Alonso, Ph.D.
Jack M.Gorman,M.D.
..
Ph.D.
#{149}ADOLESCENT
AND
CHILD PSYCHIATRY
Ezra E. H. Griff ith, M.D.
Leona L. Bachrach, Ph.D.
Thomas G. Gutheil, M.D.
Carolyn B. Robinowitz, M.D.
#{149}APA
PRACTICE GUIDELINES
Jerrold F. Rosenbaum, M.D.
#{149}CROSS-CULTURAL
ISSUES
#{149}DEPRESSION
James E. Sabin, M.D.
Robert E. Hales, M.D.
.
Carl C. Bell, M.D.
Leston L. Havens, M.D.
Thomas E. Brown, Ph.D.
Marvin I. Herz, M.D.
Joseph T. Coyle, M.D.
Eric Hollander, M.D.
Leah J. Dickstein, M.D.
Douglas G. Jacobs, M.D.
Harold I. Eist, M.D.
Michael A. Jenike, M.D.
Mary Jane England, M.D.
#{149}ADMIN1STRATIVE
PSYCHIATRY
Charles W. Popper, M.D.
Paul S. Appelbaum, M.D.
Allan Beigel, M.D.
. . some ofthe featured
sessions
DSM-IV
Melvin Sabshin, M.D.
#{149}DUAL
DIAGNOSIS
Carl Saizman, M.D.
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ECT
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PSYCHIATRY
Steven S. Sharfstein, M.D.
John S. Mcintyre, M.D.
Max Fink, M.D.
Robert Micheis, M.D.
Michael B. First, M.D.
Sheldon I. Miller, M.D.
#{149}GERIATRIC
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Leonard I. Stein, M.D.
Nada L. Stotiand, M.D.
Jeremy A. Lazarus, M.D.
Joseph T. English, M.D.
#{149}FEMALE
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E. Fuller Torrey, M.D.
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#{149}RECOVERED
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Robert B. Miliman, M.D.
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IName
Daily advance
registration
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For more information,
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evoke in the therapist
is in conflict
with the ultimate
goals of personal
growth
and autonomy
and that the
therapist’s
resistance
to being placed
in that role is intended
to best serve
the patient’s
wel&rc.
Thus the therapist
must give pnimacy to beneficence
when
the patient truly is unable
to control
selfdestructive
impulses.
However,
when the patient
engages
in suicidal
behavior
in the interest
of a regressive dependent
wish to be rescued by
the therapist
but is actually
capable
of responsible
action
if enabled
to
take it,then the therapist must give
primacy
to autonomy.
By being
respectful
of the patient’s autonomy,
even to the point of
recognizing
the patient’s
ultimate
capacity
to take his or her life (although,
ofcourse,
not encouraging
or condoning
self-destructive
behavion), the therapist
invites
open communication
about
the distress
that
has led to the suicidal
feelings.
By
encouraging
autonomy,
the therapist
helps the patient
work toward
control ofhis or her life.
Conclusions:
the
clinical-ethical
interface
The successful
management
of the
suicidal
patient
thus illustrates
the
need for flexible
dynamic
application
of ethical
principles.
Rigid
adherencc to the principle
of autonomy,
which
is currently
the primary
focus
in ethical
studies
and discussions,
would
unnecessarily
risk the lives of
acutely
suicidal
patients.
Rigid
interpretation
of the principle
of beneficence
would
unnecessarily
risk
consigning
many
chronically
depressed
patients
to lives of dependency
and
chronic
patienthood.
When
the patient
realizes what such
therapeutic
failure
entails,
this approach may result in the very act that
it seeks
to prevent-the
patient’s
suicide.
Clearly,
what is called
for in the
treatment
of sucidal
patients
is not
the rigid application
ofethical
pninciples. A philosophical
alternative
to
such rigidity
has been offered by Arras (3) andJonsen
and Toulmin
(17),
who propose
a new case-based
casuistry
in which
the ethical
principles
that arc most applicable
to the par-
Psychiatric
Services
September
1995
ticular
case are discovered
in the
clinical
situation.
This
approach
need
not entail
sacrificing
useful
bioethical
principles
to a philosophy
of situational
ethics
in which
“anything goes.” Rather, it calls for clinicians to be flexible
in prioritizing
bioethical
principles
that can usefully
inform
clinical
decision
making.
The management
of suicidal
behavior
illustrates
the need for flexibility at the clinical-ethical
interface.
Aggressive
measures
to prevent
suicide are appropriate
in the management ofacutely
suicidal
patients
and
those with periodic
recurring
psychoses. For these patients,
the ethical
principle
ofbeneficence
guides
clinical decisions.
However,
many
patients who chronically
engage
in suicidal behavior
are best treated
more
flexibly
with the focus on expanding
patients’
assumption
of nesponsibility for their own lives. For these patients, the ethical principle
of autonomy is prioritized.
Preserving
a dynamic
clinical-ethical
interface
is
more appropriate
than rigidly
applying ethical principles.
References
1.
and
the ethics ofmedicine.
Canadian
ofPsychiatry
31:91-96,
1986
Journal
10.
Szasz T: The
tween
Survival
Wolman
B,
Gardner, 1976
1 1 . Pellegnino
Psychiatric
EthOxford
University
ED,
Good:
Patient’s
Thomasma
DC:
The Restoration
For the
of Be-
neficence inHealthCare.
NewYork,OxfordUniversityPress,1988
12. Gunderson
J: Borderline
Personality
Disorder.
Psychiatric
13.
Washington,
Press,
1984
Hendin
with
reference
American
Journal
1150-1158, 1991
14.
15
DC,
American
H: Psychodynamics
particular
of suicide,
to the
young.
of Psychiatry
148:
Olin H: Psychotherapy
of the chronically suicidal patient.
American
Journal
ofPsychotherapy 30:570-575, 1976
.
Silver D, Rosenbluth
process,
in Handbook
orders.
Edited
M. New
York,
M: The
assessment
ofBorderline
by Silver
International
D,
Dis-
Rosenbluth
Universities
Press,1992
16.
Schwartz
D, Flinn D, Slawson
P: Treatment ofthe
suicidalcharacter.
American
Journal
of Psychotherapy
28:194-207,
1974
17. Jonsen
AR,
Casuistry:
A
ing.
Berkeley,
Press,
1988
Institute
Bloch S, ChodoffP(eds):
ics, 2nd ed. New York,
ethics
of suicide,
in Beand Suicide.
Edited
by
Krauss
H. New
York,
Services
Toulmin
5: The
History
of Moral
Universityof
Abuse
of
Reason-
California
on Psychiatric
Set for Boston
Press,1991
2.
Beaucharnp
ofBiomedical
Childress
JF: Principles
Ethics,
3rd ed. New York,
University
Press, 1989
Oxford
3.
U,
Arras JD: Getting
down
to cases:
the
revival
ofcasuistry
in bioethics.
Journal
of
Medical
Philosophy
16:29-51,
1991
4. Beck
AT, Brown
G, Berchick
RJ, en al:
Relationship
between
hopelessness
and
ultimate
suicide:
a replication
with psychiatric
outpatients.
American
Journal of
Psychiatry147:190-195, 1990
5.
Best
from
dian
6.
Heyd
E: Suicide:
ethical
and moral
issues
a theological
perspective.
CanaJournal
of Psychiatry
31:97-100,
1986
D, Bloch
Psychiatric
ChOdOfF,
Press,
7. Hawnon
British
5: The
Ethics.
P. New
ethics
Edited
York,
1981
K: Assessment
Journal
ofsuicide,
in
by Bloch
S,
Oxford
University
of suicide
of Psychiatry
risk.
150:145-
153, 1987
8.
Kreitman
N: The clinical assessment
and
management
of the suicidal
patient,
in
Suicide.
Edited byRoyA.
Baltimore,
Wilhams
& Wilkins,
1986
9. Sakinofsky
VoL 46
I, Swam G: Suicidal
No.9
The Institute
on Psychiatric
Services
(formerly
called
the Institute
on
Hospital
and Community
Psychiatry) will be held October
6-10
at the
Boston
Marriott
Copley
Place. The
program
includes
major
sessions
on
managed
care issues, psychopharmacology,
violence,
substance
abuse,
and APA’s
new practice
guidelines.
Thirteen
CME courses
will be offered. Fifteen
mental-health-related
organizations
will meet in conjunction with the Institute.
H. Richard
Lamb,
M.D.,
of Los
Angeles
is chairman
ofthe
program
committee.
For more information,
see the preliminary
institute
program
published
in thejune
1995 issue of Psychiatric
Services on contact
Wanda
Sheridan,
Institute
on Psychiatnic
Services,
American
Psychiatric Association,
1400
K Street,
N.W.,
Washington,
D.C.
20005;
telephone,
202-682-6314.
patients
921
depression
one found
is nearly
identical
in our study.
A majority
of patients
to the
in our
study
(54 percent)
and in the study
by Ross and colleagues
(68 percent)
were diagnosed
as having at least one
comorbid
psychiatric
disorder.
Haliicas and associates
(16) found that 56
percent
ofthe 7 1 inpatient
female alcoholics
they examined
met lifetime
criteria
for an additional
psychiatric
diagnosis;
unipolar
depression
(24
percent)
and sociopathy
(19 percent)
were the most prevalent
disorders.
Hesselbrock
and co-workers
(17) cxamined
current
and lifetime
psychopathology
in 90 hospitalized
female
alcoholics.
Depression
(38 percent)
and phobias
(29 percent)
were the
most prevalent
current
psychiatric
disorders;
the lifetime
prevalence
of
antisocial
personality
disorder
was
20 percent.
General
population
surveys
support
the association
between
substance
dependence,
personality
disorders,
and
depression.
Alcoholabusing
or -dependent
women
in the
Epidemiologic
Catchment
Area
(ECA) study were 2 .7 and 1 2 times
more likely, respectively,
to receive a
lifetime
diagnosis
of major
depression or antisocial
personality
disonder, respectively,
than women
in the
general
population
who did not have
an alcohol
use disorder
(18).
For
women
in the ECA study with alcohol abuse
or dependence,
lifetime
prevalence
rates were 19 percent
for
major
depression
and 1 0 percent
for
antisocial
personality
disorder.
Conclusions
Substance
use disorders
are endemic
in the population
of women
treated
in VA hospitals.
Women
with substance
use disorders
had higher
rates
of most
psychiatric
disorders
and
some medical
disorders
than women
without
substance
use disorders.
Female veterans
with substance-related
diagnoses
had higher
rates of inpatient utilization
than female veterans
with no substance
use disorders.
A
majority
of the women
with
substance use disorders
who were hospitalized
in the first half of fiscal year
1991 were rehospitalized
by the end
ofthe
fiscal year.
Efforts
should
be undertaken
to
Psychiatric
Services
September
1995
replicate
these findings
using
standardized
diagnostic
procedures
with
other samples
of women
oflower
socioeconomic
status.
Prevalence,
alcoholism
investigation
was funded
by interagency agreement
RA-ND-90-37
with
the financing
and services
research
branch of the Division
of Applied
Research
ofthe National
Institute
on Drug
Abuse.
References
5: Women,
Comprehensive
alcohol,
Edited
York, Marcel-Dekker,
AlcoholAddiction.
New
and drugs,
Handbook
ofDrug
14.
Vital and Health
Statistics:
National
Hospital
Discharge
Survey:
Annual
Summary
1987. Hyattsville,
Md, NationalCenter
for Health Statistics,
1989
in
2. Wilsnack
SC, Klassen
AD, Schur BE,
et al: Predicting
onset and chronicity
of women’s
problem
drinking:
a fiveyear longitudinal
analysis.
American
Journal
ofPublic
Health
81:305-317,
1991
3. Institute
of Medicine:
Broadening
the
Base ofTreatment
for Alcohol Problems.
Washington,
DC, National
Academy
Press,
1990
Affairs,
5. Wilsnack
RW,
AD: Women’s
Wilsnack
SC, Kiassen
drinking
and drinking
problems:
patterns
from a 1 98 1 national
survey.
American
Journal
of Public
Health
74:1231-1238,
1984
6. Wilsnack
SC, Wilsnack
RW: Epidemiology of women’s
drinking.
Journal
of
SubstanceAbuseTreatment
3: 1 33-1 57,
1991
Moos
Services
Abuse
RH, Pasch
Utilization
Patients
CostsforFY9O.
ment
8.
Ross HE, Glaser
FB, Germanson
T: The
disorders
in patients with alcohol and otherdrug
problems. Archives
of General
Psychiatry
45:1023-1031,
1988
HalikaSJA,
Herzog MA, Mirassou MM,
et al: Psychiatric
diagnosis among female
alcoholics.
Currents
in Alcoholism
8:
283-291, 1981
17.
Hesselbrock
MN, Meyer RE, KeenerJJ:
Psychopharmacology
in hospitalized
alcoholics. Archives ofGeneral
Psychiatry
42:1050-1055,
1985
18.
HelzerJC,
Pryzbeck
TR: The co-occurofalcobolism
with other psychiatnc disorders in the general
population
and its impact on treatment.
Journal
of
Studies on Alcohol 49:2 19-226,
1988
rence
1990
4. Survey ofMedical
System Users. Washington, DC, Office ofthe Deputy Assistant Secretary
for Planning
and Management Analysis,
Department
of Veterans
7.
Care:
prevalenceofpsychiatric
and
byMillerNS.
1991
of
patients.
Alcoholism
Screening
Procedures Should Be Improved.
Washington, DC, General Accounting
Office,
1991
15.
VA Health
and treatment
hospitalized
1989
JAMA261:403-407,
16.
1 . Blume
in
13.
Acknowledgment
This
detection,
R: Health
for VA Substance
and
Utilization
PaloAlto,Calif,
ofVeterans
Diagnostic
B, Swindle
Affairs,
and
Depart-
1991
and
Statistical
Manual
of
MentalDisorders,
3rd ed, rev. Washington, DC, American
Psychiatric
Associa-
tion,1987
9. International
Classification
of Diseases, 9th rev, 4th ed. Los Angeles,
Practice
Management
Information
Corp, 1992
10.
Moos RH, Swindle R, Pasch B: Health
Services
Utilization
for VA Substance
Abuse Patients:
Utilization
and Costs for
Fiscal
Year 1989. Palo Alto, Calif, Department
ofVeterans
Affairs, 1991
11.
Moos RH,MertensJR,BrennanPL:Patterns ofdiagnosis
and treatment
among
late-middle-aged
and older substance
abuse patients.Journal
ofStudies
on Alcobol 17:479-487,
1993
12.
Moore
VoL 46
RD,
Bone
No.9
LR, Geller
Reviewers
Needed
Psychiatric
Services seeks
expert
reviewers
in the following
areas:
. Outcome
research,
particularly in the area of psychopharmacological
treatment
ofmental
disorders
I
Rating
scales
for symptoms,
outcome,
and other aspects
of treatment
. Dual diagnosis (mental illness
and drug
abuse
and mental
illness
and mental
retardation)
. Rural psychiatric
services
. Patient
and consumer
perspectives and attitudes
Psychiatric
Services uses reviewers
from all mental
health
and related
disciplines.
Reviewers
should
be familiar
with the literature
in their aeas of expertise,
should
have published in peer-reviewed
journals,
and
should
be familiar
with the content
and focus ofPsychiatric
Services.
Prospective
reviewers
should
send
a curriculum
vitae,
specifying
areas
ofinterest,
toJohn
A. Talbont,
M.D.,
Editor,
Psychiatric
Services, American
Psychiatric
Association,
1400 K Street,
N.W., Washington,
D.C. 20005.
G, en al:
937
becomes
wider. It also allows time for
the unhurried
exchange
of infonmation between
staffand
patients
about
the transition
from hospital
to community,
housing
for visits to different
and discussion
with
types of
former
patients
who have already
made the
transition,
and
for familiarization
with the localities
eventually
chosen.
In addition,
the houses
facilitate
the development
of social networks
that
can be maintained
after
discharge.
This
feature
is particularly
important,
because
mutually
suppontive
relationships
are essential
if
former
patients
arc not to become
socially
isolated
(3).
A wide range of housing
formats
in the community
is necessary
to caten to the needs and choices
of prepanation-house
residents
when
they
move on. An important
pant of this
range
consists
of housing
projects
specifically
designed
to provide
mdividual
apartments
for privacy
combined
with communal
areas
that allow social contacts
and staff support
when required
(2). Eighty
former
patients arc now accommodated
in five
schemes
of this type, and their quality of life and satisfaction
levels arc
very high.
We have found this approach
invaluable
in resolving
the dichotomy
between
patients’
needs
for autonomy and fonstructured
environments
with support
that Minsky
and associates see as the basis of patient-staff
differences
in housing
preferences.
DAVID ABRAHAMSON,
F.R.C.PSYCH.,
F.R.C.P.I.
Dr. Abrahamson
is a consultant
psychiatrist
with
Redbridge
Health
Care
(Goodmayes
Hospital)
and Newham
Mental
Health
Rehabilitation
Team in
Essex and London,
England.
References
1 . Minsky
of the
5, Reisser
beholder:
inpatients
and
chiatric
Services
2. Abrahamson
tionalization,
GG, Duffy M: The eye
housing
preferences
of
their
treatment
teams.
46:173-176,
1995
Psy-
D: Housing
and deinstituin Dimensions
of Commu-
Mental Health Care. Edited by Wel1cr MPI, Muijen
M. London,
Saunders,
nity
1993
3. Meltzer E, Kemp P, Smith B: Social networks in a cluster ofthree group homes for
the mentally
ill.Journal
ofMental
Health
3:263-270,
1994
952
Attachments
to
the
Hospital
been
total care may be indicated.
The
and confusion
of community
life may exacerbate
inner disonganization.
Patients
may experience
loneliness,
feelings
of vulnerability,
and
homesickness
for the friends
left behind in the state hospital.
They may
meet new people
in outpatient
programs,
but,
as we all have expenienced, new acquaintances
are no substitute
for old friends.
The measures
that Dr. Swett suggested
arc an excellent
way to identify patients
at risk for readmission
within
30 days. A first step toward
avoiding
neadmission
may be to interview
these
patients
individually
and ask them
specifically
what
they
need to live in the community.
I am
not sure what
the answers
are. Providing
good
community
care is a
complex
and difficult
task.
ELIZABETH
W. FARRELL,
M.S.W.,
L.I.C.S.W.
noise
To the Editor:
In the article entitled
“Symptom
Severity
and Number
of
Previous
Psychiatric
Admissions
as
Predictors
of Readmission”
in the
May 1995 issue, Dr. Swett
(1) suggested
that symptom
acuity (as measured by scores on the thought
disorden factor and the self-neglect
qucstion of the Brief Psychiatric
Rating
Scale) and a large number
of previous
admissions
can be useful
predictors
of readmission
to the state hospital
within
30 days.
I would
like to add some other
points
to Dr. Swett’s
discussion
of
symptom
acuity among
patients
who
arc at high risk for readmission.
Because of their many previous
admissions, these patients
have developed
attachments
to hospital
staff. In our
state hospital,
patients
who are readmitted
within
30 days arc returned
to the same unit to ensure
continuity
of treatment.
Persons
with
schizophnenia
cannot
be expected
to attach
readily
to new support
persons.
Such
patients
have had little opportunity
to form attachments
in the community. Most
have a limited
range
of
adaptive
responses,
which
makes
adjustment
to new environments
difficult.
When
patients
have a great
deal
ofthought
disturbance
or inner disorganization,
they need the structune that a hospital
provides.
From
their
point
of view,
perhaps
their
return
to the hospital
indicates
that
they
know
what
they
need.
They
need
help
with
self-cane.
When
one’s thoughts
interfere
with one’s
ability
to organize
activities,
what
a reliefto
have clean sheets,
clothes,
and meals provided!
In the community,
a patient
with
acute
symptoms
may have trouble
crossing
the street to get to a grocery
store, let alone marshalling
the skills
involved
in using a laundromat.
Because poor self-cane
and thought
disturbance
combine
to make a person
look different,
others
arc likely
to
view him or hen as a “weirdo.”
Providers
of outpatient
care may
need
to attend
to the difficulties
many ofthcsc
patients
have in establishing
bonds with new caretakers;
a
more gradual
reduction
in what has
Psychiatric
Services
Ms. Farrell
is assistant
professor in the
department
ofbehavioralhealth
and psychiatry
at West Virginia
University
School of Medicine.
She urk
at the
William
R. Sharp,
Jr.,
Hospital
in
Weston,
West Virginia.
Reference
1 . Swert
ofprevious
dictors
vices
C: Symptom
psychiatric
severity
and
admissions
of readrrnssion.
46:482-485,
1995
First-Person
Sought
Psychiatric
number
as pre-
Ser-
Accounts
for Column
Psychiatric
Services
is seeking
firstperson
accounts
of experiences
with
mental
illness and treatment
for the
Personal
Accounts
column,
which
is
now published
every other month.
Submissions,
which
should
not cxceed 1 ,600 words,
should
be sent to
the column
editor,
Jeffrey
L. Gellen,
M.D.,
M.P.H.,
Department
of Psychiatny,
University
of Massachusetts
Medical
School,
55 Lake
Avenue
North,
Worcester,
Massachusetts
01655.
September
1995
VoL 46
No.9
Attend
the
Your Chance.
Couldn’t
Here’s
Live Audiotapes
1995
Meeting?
.On Audiotape
.
of the Proceedings
Annual
Available
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