Newsletters of 2014
Date Newsletter title Download

1 - 2014
  • Diacerein - Risk of severe diarrhea and potentially harmful effects on the liver.
  • Pharmacovigilance Committee (PVC) - reconfirm suspension & recall of
    Rosiglitazone containing products in Egypt.

  • FDA warns consumers not to use muscle growth product.

2 - 2014
  • Regional center in Cairo - First hospitals QPPVs training workshop
  • Warfarin - case reports of congenital anomalies due to exposure during pregnancy
  • Tramadol - Risk of Abuse and Dependence

3 - 2014
  • Propylthiouracil - Case of Congenital Hypothyroidism due to maternal exposure during pregnancy in Alexandria.
  • Phenytoin injection - four cases of Elevated liver enzymes in Cairo.
  • Ceftriaxone - Eleven cases of Serious Adverse Drug reactions Development with Direct IV Push in Alexandria.

4 - 2014
  • The common Arab Guidelines for pharmacovigilance on March 2014.

  • Abimol® (Paracetamol); Ventolin® (albuterol), batch recall due to inactive materials “mix-up” during Manufacturing.

  • Dexamethasone injection - risk of congenital anomaly due to administration during pregnancy.

5 - 2014
  • EPVC launch a new database system for tracing.
  • Diacerein - update on risk of severe diarrhea and potentially harmful adverse effects on the liver.
  • Metoclopramide - Pharmacovigilance Committee recommends use restrictions.
  • Meclizine - restricted use in pediatrics.
  • Cyclizine - restricted use in children under 6 years of age.
  • Domperidone - Serious Cardiovascular adverse events.

6 - 2014
  • Ranitidine Hydrochloride - Development of severe rash, tachycardia and anaphylaxis; with direct and rapid IV push - in Alexandria.
  • Adcokion® (Phytomenadione) ampoule - Case of old male died after intravenous (IV) Push administration - In Alexandria.
  • Dacarbazine Citrate - Case of Product Compounding quality issue - in Alexandria.

7 - 2014
  • Egyptian Pharmaceutical Vigilance Center (EPVC) Website - Recovery of our own website domain (www.epvc.gov.eg).
  • EPVC regional center in Cairo - Hospitals QPPVs Pharmacovigilance training workshop.
  • Pioglitazone - Risk of Bladder Cancer.
  • Alizapride - Benefit-Risk Balance is favorable in Identified Indications Only.
  • Fercayl® (Iron Dextran) - Egyptian Pharmacovigilance Committee Decision.

8 - 2014
  • Sovaldi® (Sofosbuvir) tablet - Approval for Treatment of Chronic Hepatitis C (CHC) in Egypt.
  • Domperidone - Pharmacovigilance Committee recommends new restrictions and label update.
  • Lidocaine - Pharmacovigilance Committee recommends new restriction and label update Concerning Usage for teething pain treatment in Children

9 - 2014
  • Methotrexate - Three Death Cases Due To Toxic Epidermal Necrolysis (TEN) in children - in Mansoura University (Oncology Center).
  • Chromic (Cat gat) - Recall of Specified batch (061102) in Egypt due to Physical Characters Deviation.
  • Deltaclav® 228.5mg Suspension (Amoxicillin Trihydrate and Potassium Clavulanate) - Recall of Specified batches (31555-31554) in Egypt due to Physical Characters Deviation.
  • For Hair & Nails Capsules - Recall of Specified batches (133772-132730-132729-132728) in Egypt Based on Inspection Committee Decision.
  • Epoetin® 4000 IU (Recombinant erythropoietin) - Recall of Specified batch (0414456) in Egypt due to Physical Characters Deviation.
  • Controloc® 40 mg vial (Pantoprazole) - Recall of Counterfeited batches in Egypt.

10 - 2014
  • The first meeting of the Eastern Mediterranean Region, Arab countries of Pharmacovigilance - Rabat/Morocco.
  • Succinylcholine - Death case due to malignant hyperthermia in a male patient in Cairo.

11 - 2014
  • The 37th Annual Meeting of representatives of the National Centers participating in the WHO Programme for International drug Monitoring - Tianjin, China.
  • Egyptian Pharmaceutical Vigilance Center (EPVC) - Pharmacovigilance Training to Hospital Pharmacists responsible for SOVALDI® (Sofosbuvir) dispensing in Egypt.
  • Rituximab - Two Direct Healthcare Professional Communications (DHPCs) distribution Concerning “Risk of Hepatitis B reactivation” and “Usage in population known to bear a high potential risk of Hepatitis C Virus (HCV) infestation" in Egypt.
  • Denosumab - Distribution of DHPC concerning “Risk of Osteonecrosis of the jaw and hypocalcaemia” in Egypt.
  • Clopidogrel - Distribution of DHPC Concerning “association of with acquired haemophilia” in Egypt.
  • Risk of Medication Errors Resulting From Mixing-Up Similar (Look-alike) Drugs - Cairo, Egypt.

12 - 2014
  • EPVC regional center in Sohag - First hospitals QPPVs pharmacovigilance training workshop in Sohag.
  • Amantadine - Prevention of new registration applications in Egypt.
  • Ritodrine - Suspension of Production and Prevention of new applications in Egypt.
  • Combined Hormonal Contraceptives - Direct Healthcare Professional Communications (DHPC) letter distribution concerning “the difference in risk of thromboembolism between products and the importance of individual risk factors” in Egypt.
  • Beta interferons - DHPC letter distribution concerning “risk of thrombotic microangiopathy and nephrotic syndrome” in Egypt.
  • Fingerstick Devices – The risk of infection transmission.