Effexor side effects, Effexor birth defects lawsuit

Transcription

Effexor side effects, Effexor birth defects lawsuit
Effexor side effects, Effexor birth
defects lawsuit
The drug Effexor is prescribed for depression and is in the class
of drugs known as SNRIs (serotonin norepinephrine reuptake
inhibitors).
“Babies of women
exposed to SNRIs
during late pregnancy
may develop
complications that
require hospitalization,
respiratory support,
and/or tube feeding.”
The FDA requires all antidepressants to carry a black box warning with a
generic warning about the possibility of suicidal risk. Most recent research
indicates that patients taking venlafaxine, generic for Effexor, are at an
increased risk of suicide.
Effexor is the first and most commonly used SNRI introduced by Wyeth
in 1994. Other SNRIs are Pristiq, Cymbalta, Meridia, and Reductil. Some
SNRIs like Meridia and Reductil are marketed for weight loss.
Newer than SSRIs, SNRIs increase the levels of two neurotransmitters
in the brain that are known to play an important part in mood, serotonin,
and norepinephrine. SSRIs also known as selective serotonin reuptake
inhibitors only act on the serotonin.
Pregnancy and SNRIs
For more information contact:
Anapol Schwartz, P.C.
(866) 735-2792
Gregory Spizer, Esquire or
Michael H. Monheit, Esquire
©2012 All Rights Reserved.
Babies of women exposed to SNRIs during late pregnancy may develop
complications that require hospitalization, respiratory support, and/or
tube feeding. Other symptoms experienced by newborns are: seizures,
lack of oxygen in the blood, tremors, difficulty breathing, difficulty feeding,
constant crying, and irritability.
PPHN is associated with significant complications and even death. Women
who take SNRIs after week 20 of pregnancy have a six-fold increase of
delivering a baby with PPHN.
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Drug makers have an ethical responsibility to make safe drugs and to
properly warn people who take these drugs (in this case pregnant women)
about the possible problems leading to devastating circumstances.
Effexor birth defects lawsuit
In Boyer & Boyer v. Wyeth Pharmaecuticals, et al., plaintiffs Glenn and
Lauren Boyer had a baby girl named Adelaide. Shortly after taking her
first breath on February 11, 2010, it was discovered that their baby
suffered lethal cardiac anomalies, including severe left hypoplastic heart,
a malformed aorta, no aortic value, a malformed mitral valve, and other
related conditions. The Boyers allege that the fatal heart anomalies were
caused by Mrs. Boyer’s use of EFFEXOR®.The Boyers have filed an
Effexor birth defect lawsuit and are represented by Thomas Anapol and
Gregory Spizer of Anapol Schwartz, among others.
Heart Birth Defects, Congenital
Effexor Side Effects
Some heart birth defects are: lethal cardiac anomalies, left
hypoplastic heart, malformed aorta, no aortic valve, and
malformed mitral valve.
Hypoplastic left heart syndrome (HLHS) happens when parts of the left
side of the heart (mitral valve, left ventricle, aortic valve, and aorta) do
not develop completely. HLHS is present at birth which also means the
condition is congenital.
Fetal cardiac anomalies are common; early detection of these anomalies
enables early referral to care centers with the right expertise. A routine
antenatal ultrasound administered between 18 and 22 weeks enables
detection of most of these kinds of malformations.
Heart Birth Defects
Congenital anomalies are the reasons for a sizeable proportion of
childhood morbidity and mortality. Approximately 3 percent of newborns
have a serious handicap or potentially lethal condition; in long-term studies
the frequency is much higher.
In patients with this condition, the left side of the heart is unable to send
enough blood to the body. As a result, the right side of the heart must
maintain the circulation for both the lungs and the body. The right ventricle
can support the circulation to both the lungs and the body for a while, but
this extra workload eventually causes the right side of the heart to fail.
Copyright © 2012 All rights reserved. Anapol Schwartz, P.C.
Read more information online at www.anapolschwartz.com.
Effexor
||
What defines HLHS?
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Most of the structures on the left side of the heart are too small and
underdeveloped to provide enough red blood flow for the baby's
needs.
The small left ventricle, which needs to be large enough and strong
enough to pump blood out to the body, doesn't function effectively.
Other left heart structures can be underdeveloped in varying
degrees—including the mitral valve, the aortic valve, and the aorta
itself.
Effexor Infant Deaths
Neonates exposed to Effexor, other SNRIs, or SSRIs, late in
the third trimester have developed complications requiring
prolonged hospitalization, respiratory support, tube feeding, and
Effexor infant death.
These problems are consistent with either a direct toxic effect of SSRIs
and, or, possibly, a drug discontinuation syndrome.
If Effexor is used until or shortly before birth, discontinuation effects in the
newborn should be considered. According to the results of a retrospective
cohort study, discontinuation effects typically appear during the first day of
life and can last up to five days after birth.
Data reported on 150 women exposed to Effexor during pregnancy
revealed 125 had live births, 18 had spontaneous abortions, and seven
had therapeutic abortions. Two of the babies had major malformations.
These complications can arise immediately upon delivery. Do
not breast feed while taking Effexor.
Effexor complications include respiratory distress, cyanosis (turning blue
because of lack of oxygen), apnea (breathing stopped or greatly reduced),
seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia,
hypotonia (severely decreased muscle tone), hypertonia (excessive degree
of muscle tone), hyperreflexia (overactive reflexes), tremor, jitteriness,
irritability, and constant crying.
Doctors prescribing Effexor for pregnant women during their
third trimester should carefully weigh the potential benefits of
treatment against the risks and complications.
A study released in May 2010 by the Canadian Medical Association
Journal suggests use of Effexor doubles the risk of miscarriage.
Copyright © 2012 All rights reserved. Anapol Schwartz, P.C.
Read more information online at www.anapolschwartz.com.
Effexor
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Effexor Pregnancy Category
Effexor Pregnancy Category is C. The Pregnancy Category C
means that there have been no controlled studies on pregnant
women, only studies on animal reproduction. Pregnancy
Category C means that the potential benefits may outweigh the
risks.
Are women of childbearing age or women who are trying to get pregnant
adequately warned about the Effexor pregnancy category risks vs.
benefits?
Every drug issued by the FDA is issued a pregnancy category which
assesses the risk of fetal injury when taking the drug. Clinical trials on
pregnant women are unethical so drugs are tested on animals.
Are the pregnancy categories strong enough to prevent birth defects?
Effexor along with other SNRIs and most SSRIs and most drugs in general
fall into Pregnancy Category C. The lowest dose for the shortest amount of
time is optimal but drugs for depression and other medical conditions are
long term.
Here is the rundown on the Pregnancy Category:
Pregnancy Category A - Adequate and well-controlled human studies
have failed to demonstrate a risk to the fetus in the first trimester of
pregnancy and there is no evidence of risk in later trimesters. (Examples:
Metamucil, milk of magnesia, Tums, insulin, Imodium A-D)
Pregnancy Category B - Animal reproduction studies have failed to
demonstrate a risk to the fetus and there are no adequate and wellcontrolled studies in pregnant women. Or animal studies have shown
an adverse effect, but adequate and well-controlled studies in pregnant
women have failed to demonstrate a risk to the fetus in any trimester.
(Examples: Tylenol, Benadryl, Pepcid, Dramamine)
Pregnancy Category C - Animal reproduction studies have shown an
adverse effect on the fetus and there are no adequate and well-controlled
studies in humans, but potential benefits may warrant use of the drug in
pregnant women despite potential risks. (Examples: Lunesta, Ambien,
Wellbutrin, Allegra, Sudafed)
Pregnancy Category D - There is positive evidence of human fetal
risk based on adverse reaction data from investigational or marketing
experience or studies in humans, but potential benefits may warrant
use of the drug in pregnant women despite potential risks. (Examples:
Tetracycline, Paxil, Dilantin, Advil/Motrin)
Copyright © 2012 All rights reserved. Anapol Schwartz, P.C.
Read more information online at www.anapolschwartz.com.
Effexor
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Pregnancy Category X - Studies in animals or humans have demonstrated
fetal abnormalities and/or there is positive evidence of human fetal
risk based on adverse reaction data from investigational or marketing
experience, and the risks involved in use of the drug in pregnant women
clearly outweigh potential benefits. (Examples: Accutane, Thalidomide)
Effexor XR Lawsuit, Lawsuits for
Effexor
Are you looking for lawyers who deal with Effexor lawsuits?
In February 2012, a lawsuit was filed in the Philadelphia Court of Common
Pleas, for what is believed to be the first Effexor birth defect lawsuit, against
the makers of the popular antidepressant drug.
The Ohio couple who filed the case alleges the link between Effexor and
birth defects. Their baby daughter Adelaide died within days of birth from
heart complications.
“The parties involved
neglected to disclose
the birth defect risks
to physicians treating
women of childbearing age.”
—Thomas Anapol
“The information that patients – especially women who are pregnant
– receive about the medication that is prescribed to them is crucial,”
said Thomas Anapol, a Philadelphia-based attorney heavily focused in
pharmaceutical and catastrophic injury civil litigation. “This SNRI (serotonin
norepinephrine reuptake inhibitor) drug was approved by the FDA in 1993,
but the parties involved neglected to disclose the birth defect risks to
physicians treating women of child-bearing age.”
Frequently, people may hesitate contacting a law firm because they cannot
afford an Effexor lawsuit. However, if you decide to hire us, and we think
your case is the right fit for us, we will take your case on a contingency fee
basis which means if we don’t win, our lawyers don’t get paid.
With the complexity of unsafe drug litigation, our attorneys consult with an
advanced team of medical experts to build the facts in order to develop a
powerful case.
If your newborn has suffered from a heart birth defect like HLHS, other
or wrongful death while taking Effexor or another SNRI or SSRI drug
while pregnant, you may also be eligible for compensation. For a free
consultation with one of our award-winning lawyers, contact us toll free for
further information at (866) 735-2792.
Copyright © 2012 All rights reserved. Anapol Schwartz, P.C.
Read more information online at www.anapolschwartz.com.
Effexor
||