EPVC Newsletter
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EPVC Newsletter
Part I of II EPVC Newsletter March 2016 Egyptian Pharmaceutical Vigilance Center (EPVC) Pharmacovigilance Department Inside this issue: 13 Case Reports 1 from Tanta suffered from loss of vision along with eye bleeding associated with off label use of Avastin®. Case Report from 3 AlexandriaInflammatory hepatitis and raised liver enzymes with DepoProvera 13 Case Reports from Tanta suffered from loss of vision along with eye bleeding associated with off label use of Avastin®. The regional center in Cairo has received a complaint concerning 13 patients who were administered Avastin ® as treatment of Eye Disorders such as: Macular degeneration, diabetic retinopathy and retinal vein occlusion which is considered as off-label use. This led to very serious Eye Problems. Avastin ® (bevacizumab) is a vascular endothelial growth factorspecific angiogenesis inhibitor indicated for the treatment of: Metastatic Colorectal Cancer (mCRC). Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer. Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer. Malignant Glioma (WHO Grade IV) - Glioblastoma Case Reports from 5 Sohag associated with RIVO Recall from the 5 Egyptian market due to counterfeit “Batches” Recall of 7 some pharmaceutical products from the Egyptian market Volume 7, Issue 03 Labeled information: According to Avastin (bevacizumab) Summary of product Characteristics (SmPC) in EMA, it was stated under section (4.1 Therapeutic indications) that: Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. Bevacizumab in combination with capecitabine is indicated for firstline treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and Page 2 anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab in combination with interferon alfa2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinumsensitive epithelial ovarian, fallopian tube or primary 3 peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, Part I EPVC Volume 7, Issue 03 is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix". It was stated under section (4.4 Special warnings and precautions for use) that : “Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of Avastin compounded from vials approved for intravenous administration in cancer patients. These reactions included infectious endophthalmitis, intraocular inflammation such as sterile endophthalmitis, uveitis and vitritis, retinal detachment, retinal pigment epithelial tear, intraocular pressure increased, intraocular haemorrhage such as vitreous haemorrhage or retinal haemorrhage and conjunctival haemorrhage. Some of these reactions have resulted in various degrees of visual loss, including permanent blindness. It was stated under section (4.8 Undesirable effects) that: Avastin has been developed and made to treat cancer by injecting it into the bloodstream. It has not been developed or made for injection into the eye. It is therefore not authorised to be used in this way. When Avastin is injected directly into the eye (unapproved use), the following side effects may occur: Infection or inflammation of the eye globe, Redness of the eye, small particles or spots in your vision (floaters), eye pain, Seeing flashes of light with floaters, progressing to a loss of some of your vision, Increased eye pressure, Bleeding in the eye. According to Avastin® (Bevacizumab) Product Information (PI) in FDA: It was stated under section (Post marketing Experience): Page 3 Part I EPVC Volume 7, Issue 03 “Eye disorders (from unapproved intravitreal use for treatment of various ocular disorders): Permanent loss of vision; Endophthalmitis (infectious and sterile); Intraocular inflammation; Retinal detachment; Increased intraocular pressure; Hemorrhage including conjunctival, vitreous hemorrhage or retinal hemorrhage; Vitreous floaters; Ocular hyperemia; Ocular pain or discomfort” Regulatory Actions taken : 1. EPVC (The Egyptian Pharmaceutical Vigilance Center) requested from Roche Scientific Office in Egypt to distribute a DHPC (Dear Healthcare Professional Communication) among the ophthalmologists to highlight that “Avastin is not suitable for intravitreal use” and the risks of this off label use. Moreover Roche mentioned in the DHPC that the company didn’t perform any ocular efficacy or safety testing with Avastin, consequently its use intravitrealy is not approved in any country in the world. 2. CAPA (the Central Administration for Pharmaceutical Affairs) obligated Egydrug to ban distribution of Avastin on Ophthalmology Hospitals. References: 1. 2. Avastin - Summary of Product Characteristics (SPC) - (EMEA) (Click here) Avastin Label-(FDA) (Click here) Case Report from Alexandria-Inflammatory hepatitis and raised liver enzymes with Depo-Provera The regional center in Alexandria has received an ICSR concerning a female who was administered Depo-Provera as a treatment for vaginal bleeding. Three days later, the patient developed inflammatory hepatitis with increased liver enzymes; SGOT and SGPT levels reached 600 U/ L and 900 U/L respectively. The patient has undergone tests for Hepatitis virus A, B and C, but they were all negative. The patient is on liver support as a treatment for the case but not recovered yet. The patient didn't suffer previously from any liver disease. Depo-Provera injectable suspension contains 150 mg/ml medroxyprogesterone acetate (which is a derivative of progesterone). It is a long-term contraceptive agent, which gives 12 weeks continuous contraception with each injection. It may also be used for short-term contraception in some cases. Labeled information: According to Depo-Provera Summary of Product Characteristics (SmPC) it was stated under section (4.8 Undesirable effects), that the following adverse events were reported: "Hepatobiliary disorders: abnormal liver enzymes, jaundice (uncommon), disturbed liver function (not Part I EPVC Page 4 Volume 7, Issue 03 known)." It was also stated under section (4.2 Posology and method of administration) that: "The effect of hepatic disease on the pharmacokinetics of Depo-Provera is unknown. As Depo-Provera largely undergoes hepatic elimination it may be poorly metabolised in patients with severe liver insufficiency." The results of certain laboratory tests may be affected by the use of Depo-Provera: Decreased Increased Gonadotrophin levels Plasma progesterone levels Urinary pregnanediol levels Thyroid function tests (T3 uptake levels) Glucose tolerance test Metyrapone test Liver function tests Thyroid function tests (protein bound iodine levels) Coagulation test values for prothrombin (Factor II), and Factors VII, VIII, IX and X Plasma oestrogen levels Plasma cortisol levels Recommendations for Healthcare Professionals: Depo-Provera is contraindicated in patients with the presence or history of severe hepatic disease, whose liver function tests have not returned to normal. Medroxyprogesterone is extensively metabolized in the liver. Most products are contraindicated in patients with hepatic impairment. If needed for the palliative treatment metastatic endometrial carcinoma, monitor closely; withhold or discontinue treatment if liver dysfunction develops and do not resume until hepatic function has returned to normal. Whether administered alone or in combination with estrogen, Depo-Provera should not be employed in patients with abnormal uterine bleeding until a definite diagnosis has been established and the possibility of genital tract malignancy eliminated. Depo-Provera is contraindicated as a contraceptive in known or suspected hormone-dependent malignancy of breast or genital organs. History or emergence of the following conditions requires careful consideration and appropriate investigation: migraine or unusually severe headaches, acute visual disturbances of any kind, pathological changes in liver function and hormone levels. In women with significant lifestyle and/or medical risk factors for osteoporosis, other methods of contraception should be considered prior to use of Depo-Provera. Before administration of Depo-Provera, liver enzymes test should be done. References: 1. Emc-Depo-Provera, SmPC (Click here) 2. Drugs.com- Depo-Provera, SmPC (Click here) Page 5 Part I EPVC Volume 7, Issue 03 Case Reports from Sohag associated with RIVO The Egyptian pharmaceutical Vigilance regional center in sohag had received two ICSRs about Rivo tablets. First ICSR: An infant male patient, 4 years old, was administered Rivo 75 mg for Slight fever from a long time as a solution once daily orally as necessary. Then he suffered from vomiting blood, so the drug had been withdrawn and the reaction was recovered. Second ICSR: At 01/12/2015, an 11- years old female patient was administrated Rivo 320 mg three times daily. Then, at 02/12/2015 she suffered from bleeding from her nose so the drug has been withdrawn and she had administrated adrenaline to recover the reaction. Rivo (Acetyl Salicylic acid): A widely used analgesic, antipyretic, and anti-inflammatory agent; also used as an antiplatelet agent. Upon search , it was found that: Avoid Rivo in patients with active peptic ulcer disease. Rivo may cause gastric ulceration and bleeding. Safety and effectiveness in pediatric patients have not been established. When given to children aspirin may cause Reye’s syndrome. Reye’s syndrome: is a rare and serious disease that damages the brain and the liver. There is an association between Reye's syndrome and Aspirin used by fever caused by viral infections in children. For this reason, aspirin should not be given to children aged less than 16 years. References: 1. FDA Aspirin label (Click here) 2. emc Aspirin 300 leaflet (Click here) 3. emc Aspirin 75 patient information leaflet (Click here) Recall from the Egyptian market due to counterfeit The department of Pharmacies & Warehouse Inspection at CAPA has decided to recall the following products due to counterfeit: 1. Augmentin ES600 batch number 152044 with production date 05/2015 and Expiry date 01/2017, where the original product is manufactured by MUP for GlaxsoSmithKline. The counterfeited products can be differentiated from the authorized products as follows: Part I EPVC Page 6 Volume 7, Issue 03 Authorized packages Counterfeited Packages The Outer package: The word “Extra” is written on one side of the package correctly. The Manufacture date, Expiry date, batch number and price are imprinted on the outer side of the upper lid. The Bottle: The Manufacture date, Expiry date, batch number and price are imprinted on the label by an ink jet printer. The word “Extra” is written on the label correctly. The Outer package: The word “Extra is written incorrectly as “Extia”. The Manufacture date, Expiry date, batch number and price are imprinted on the inner side of the upper lid. The Bottle: The Manufacture date, Expiry date, batch number and price are written on the label as a part of it. The word “Extra is written incorrectly as “Extia”. 2. Augmentin 457mg syrup batch number 152044 with production date 05/2015 and Expiry date 01/2017, where the original product is manufactured by MUP for GlaxsoSmithKline. The counterfeited products can be differentiated from the authorized products as follows: Authorized packages The Outer package: The Manufacture date, Expiry date, batch number and price are imprinted on the outer side of the upper lid. Counterfeited Packages The Outer package: The Manufacture date, Expiry date, batch number and price are imprinted on the inner side of the upper lid. The bottle: The Manufacture date, Expiry date, batch number and price are imprinted on the label by an ink jet printer. “Syrup in powder form” is printed on the label. The bottle: The Manufacture date, Expiry date, batch number and price are written on the label as a part of it. “Syrup in powder form” is not printed on the label. 3. Lucentis 10mg/ml batch number S0059 with Expiry date 02/2017, the original product is imported for Novartis Pharma. The unauthorized product is illegally imported from Saudi Arabia, and can be differentiated from the authorized ones as follows: Authorized packages The importing company name is printed on the outer package. The registration number is written. The price is stated by the Egyptian pound Instructions are found on the package in French and Spanish language. Unauthorized Packages The importing company name is not printed on the outer package. The registration number is not written. The price is not stated Arabic instructions are found on the package. Part I EPVC Page 7 Volume 7, Issue 03 4. Allergan scientific office in Egypt, informed CAPA that it has discovered lots of counterfeited product labeled as ‘COMBIGAN® eye drops’ that was circulated in Egypt. Allergan has identified that the counterfeit bottles, actually contains different eye medications. Allergan has determined that the counterfeit ‘COMBIGAN® ’ bottles carry the lot numbers ‘E74469’ or ‘E73028’, these lot numbers have never been shipped to Egypt, consequently the department of Pharmacies & Warehouse Inspection has decided to recall those batches and its destruction. “Batches” Recall of some pharmaceutical products from the Egyptian market The “Drug Factories Inspection Department” at the Central Administration of Pharmaceutical Affairs (CAPA) has decided to recall Specific Batches of the following Pharmaceutical products: Pharmaceutical Product MAH Batch numbers Reason Thiotacid 600mg Eva Pharma 503458 Osipect Syrup CID 08150258 Beco tablets Misr Co. Curam 642.9mg O/S Novartis Pharma (Manufactured by Pharco) 131045 119075 118075 117075 400215 Non conformity of physical properties Non conformity of physical properties Non conformity of chemical analysis Non conformity of physical properties This decision was circulated to the Manufacturers, Marketing Authorization Holders (MAH) and Distributers for these products to discontinue distribution of stocks of and recall the amount sold of these batches ONLY from pharmacies. Necessary measures would be taken against the violators. NORCB Newsletter February 2016 National Organization for Research & Control of Biologicals Post Marketing Surveillance and Adverse Event Following immunization Department Inside this issue: Influenza vaccine may decrease atrial fibrillation risks 1 study detects method to stop HIV’s spread 1 Study shows flu vaccine's effectiveness varies for pregnant women 2 WHO renews commitment to eliminating polio 2 Researchers have isolated human monoclonal antibodies that target multiple strains of Ebola 3 Synthetic vaccine test shows immune response to Zika virus 3 Volume 7 , Issue 2 Influenza vaccine may decrease atrial fibrillation risks A new vaccine for influenza may be able to decrease the chances of developing new-onset atrial fibrillation (AF), which is an irregular or rapid heartbeat that can be related to influenza. Scientists conducted the study to determine when an influenza infection is considered a risk factor for the heart condition and to evaluate whether the influenza vaccine could decrease the chances of developing atrial fibrillation. This heart condition is the most common kind of cardiac arrhythmia. Many clinics attribute most of their hemodynamic abnormalities, frequent hospitalizations and blood clots to atrial fibrillation. Experts have stated that there is a five-fold larger risk of having a stroke with atrial fibrillation. Although the precise mechanisms of AF are not well understood, accumulating evidence indicates that inflammation and the autonomic nervous system are involved in the development of AF. The study, which involved 57,000 people, showed that people who had not received their influenza vaccines had an 18 percent higher chance of developing atrial fibrillation. According to the findings presented here, the possibility of AF should be kept in mind when patients with influenza infection complain of palpitations or experience ischemic stroke. Influenza vaccinations should be encouraged for patients, especially those who have a high risk of atrial fibrillation, to try to prevent the occurrence of atrial fibrillation and subsequent stroke. Reference Vaccine News Daily: (Click Here) Study detects method to stop HIV’s spread Researchers have detected a new way to use RNA-based drug 5-aza-C to stop HIV infections from spreading throughout the body. The drug can be altered to DNA before it makes its way into the virus, as it initiates lethal mutagenesis. This is a process where HIV evolves at such a rapid speed that the virus runs itself into exhaustion. 5aza-C stops HIV from spreading by changing into 5-aza-deoxyC, the DNA form of the drug. This enables the drug to filter into the virus and ceases the replication process from RNA to DNA. The mechanism for how 5-aza- C blocks HIV's infectivity through hypermutation. This discovery is important because RNA drugs do not cost as much as other treatments. This may help to make HIV medications and treatments more affordable for people who have HIV. More than half of the world's HIV population is concentrated in subSaharan Africa where there is very limited access to HIV drugs and treatment. Reference Vaccine News Daily: (Click Here) Page 2 Part II NORCB Volume 7, Issue 2 Study shows flu vaccine's effectiveness varies for pregnant women Scientists recently conducted a study that demonstrates that pregnant women have different T-follicular helper (Thf) cell expansion according to their trimester, which affects the effectiveness of the influenza vaccine. Officials at the Centers for Disease Control and Prevention (CDC) recommend that the influenza vaccine be administered to all pregnant women who have not received vaccinations within the last year. The officials maintain their recommendations no matter the trimester of the pregnant women. The study involved 36 pregnant women throughout the 2012 and 2014 flu seasons. The women received inactivated in- fluenza vaccines. The researchers collected blood samples before the vaccination and 14 days afterward, showing the Thf cell response was different depending on the trimester of the pregnancy. The scientists discovered that the vaccine’s impact on the Thf cells is more significant during a pregnant women’s first trimester. The study results suggest that immunological changes during pregnancy may affect the response to the vaccination,Future studies will lead to a better understanding of vaccine immunology and how pregnant women respond to antigen exposure through the course of their pregnancy. Reference Vaccine News Daily: (Click here) WHO renews commitment to eliminating polio The World Health Organization (WHO) recently renewed its commitment and reviewed its process in eliminating polio. There are 10 weeks until health professionals around the world change from a trivalent polio vaccine to a bivalent oral polio vaccine. This globally synchronized change is a significant milestone as health professionals move forward for a world without polio. At the meeting, the attendees discussed how Africa has gone for four months without detecting any wild or circulating poliovirus cases derived from vaccines. This is a first in history, and it is also the first time that there have not been any environmental positive samples in the area for four months. In the last week of January, there were no new wild poliovirus type 1 (WPV1) cases confirmed in Afghanistan. The last patient to contract the virus had paralysis onset starting on Nov.19. The cumulative number of cases for last year stands at 19; there were 28 cases confirmed in 2014.In Pakistan, there was one new WPV1 case con- firmed in the last week of January. The patient’s paralysis began on Dec. 31. For last year, the country has reported 54 cases. In 2014, there were 306 cases confirmed. In Central Africa, there have not been any new WPV1 cases confirmed in the last week or for 2015. In 2014, health officials detected 10 cases. Health professionals intend to continue taking proactive measures to eliminate polio from the world health scene. Reference Vaccine News Daily: (Click here) Page 3 Part II NORCB Volume 7, Issue 2 Researchers have isolated human monoclonal antibodies that target multiple strains of Ebola Over the last few years, there has been a surge of research to understand Ebola and develop medicines to stop it. And now researchers have isolated antibodies from Ebola survivors which they say can neutralize multiple species of the virus. The ebolavirus has claimed the lives of more than 11,000 people in West Africa in the past two years and although some countries are marking the end of the recent Ebola epidemic-the World Health Organization (WHO) also warns about the potential reemergence of the virus in 2016.Monoclonal antibodies are the product of a clone from a type of white blood cell, scaled quickly by fusing it to a cancer cell to grow it in relevant amounts for clinical use. The researchers isolated these from Ebola patients that have resisted the virus. In this study, a remarkably diverse array of virus-specific antibodies was isolated, which appeared to bind to various parts of the envelope protein of the virus. Using these monoclonal antibodies may prove an effective way to provide short-term protection to healthcare workers and those that are at risk of being exposed to the virus. They may also be used as antiviral drugs to treat patients who are already infected with the ebolavirus. Commenting on previous research which has developed and reengineered mouse antibodies which has limitations, Crowe said: "This work points the way to using fully human antibodies as the next generation of antibody therapeutics Reference: Vaccine News Daily: (Click here) Synthetic vaccine test shows immune response to Zika virus A Company recently stated that its pre-clinical testing for the company’s synthetic vaccine designed to protect people from the Zika virus has shown a robust, durable immune response in test subjects. This demonstrates that there is significant evidence that supports a vaccine to protect people from the Zika virus. There have been serious autoimmune and neurological complications that are related to Zika virus. These complications include microcephaly in newborns and Guillain-Barre syndrome. The study used constructs from DNA vaccines to target several antigens of the Zika virus. These antigens were synthetically created then delivered into the subjects with Cellectra electroporation delivery technolo- gy. With robust antibody and killer T cell responses generated by the vaccine in mice, the next step will be testing the vaccine in non-human primates and initiate clinical product manufacturing. The plan is to initiate phase I human testing of Zika vaccine before the end of 2016. Reference: Vaccine News Daily: (Click here) What is Pharmacovigilance According to the WHO, Pharmacovigilance is A call for reporting the science and activities relating to the de- Please remember that you can report suspected adverse tection, assessment, understanding and pre- reaction of medicines to EPVC, and adverse reaction vention of adverse effects or any other medicine-related problem. following immunization to NORCB using the following communication information What is the Egyptian Pharmaceutical Vigilance Center With the increasing demand for patient's safety which is becoming more stringent, the Communications information regulatory authorities are facing an increased demand for patient welfare and Central Administration of Pharmaceutical Affairs safety. Thus, The Egyptian Pharmaceutical Egyptian Pharmaceutical Vigilance Center Vigilance Center (EPVC) is constructed within Pharmacovigilance Department The Central Administration of Pharmaceutical Affairs (CAPA) Ministry of Health to be 21 Abd El Aziz Al Soud Street. El-Manial, Cairo, Egypt, PO Box: 11451 Phone: +202 – 23684288, responsible for the collection and evaluation Fax: +202 – 23610497 of information on pharmaceutical products Email: [email protected] marketed in Egypt with particular reference to adverse reactions. Furthermore, EPVC is taking all appropriate measures to: 1.Encourage physicians and other healthcare www.epvc.gov.eg professionals to report the suspected adverse reactions to EPVC. 2.Necessitate the pharmaceutical companies to systematically collect information on risks related to their medical products National Organization for Research & Control of Biologicals and to transmit them to EPVC. Post Marketing Surveillance and Adverse Event Following 3.Provide information to end-users through immunization Department adverse drug reaction news bulletins, drug 51 Wezaret El Zeraa Street, Agouza, Giza P.O. Box: 354 Dokki alerts and seminars. Phone: +202 – 37 480 478 Fax: +202 – 37480472 Email: [email protected] ext. 118
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