Newsletters of 2011
Date Newsletter title Download

1 - 2011
  • WHO -- Egypt Prequalification
  • Systemic Decongestants -- Warning for Use in Children
  • NSAIDS -- Cardiovascular Risk
  • Antiepileptics -- Risk of Suicidal Thoughts
  • Oral Bisphosphonates -- Label changes due to risk of Bone Fractures

2 - 2011
  • ACE Inhibitors--Don’t use in Pregnant Women
  • Avastin--FDA begins a process to remove breast cancer indication from the label
  • Zoledronic acid-- Risk of Renal Dysfunction
  • Fibrates-- Recommendation for use as second-line treatment 

3 - 2011
  • Paracetamol
  • Tacrolimus --Black box Warning
  • Terbutaline --FDA warning against its certain uses for preterm labor
  • Tinzaparin sodium --Not recommended to use in elderly patients with renal impairment

3 - 2011
  • Paracetamol
  • Tacrolimus --Black box Warning
  • Terbutaline --FDA warning against its certain uses for preterm labor
  • Tinzaparin sodium --Not recommended to use in elderly patients with renal impairment

4 - 2011
  • Tianeptine—Misuse by drug addicts
  • Risk of oral birth defects in children born to mothers taking topiramate
  • Risk of low magnesium levels with long-term use of Proton Pump Inhibitor drugs (PPIs) 

5 - 2011
  • Benzocaine Topical Products-- Risk of Methemoglobinemia
  • Mefenamic acid -- Precautions and contraindications
  • Insulin combined with pioglitazone-- Risk of cardiac failure
  • BCG Vaccine -- Incidence of lymphadenopathy

6 - 2011
  • Duxil-- Withdrawal due to Unfavorable risk benefit ratio
  • Alpha-Chemotrypsin-- Cancellation
  • Response to Japan Nuclear concern
  • Atypical antipsychotics--Reminder to monitor and manage weight, glucose, and lipid levels
  • FDA Approves New Drug for Type 2 Diabetes

7 - 2011
  • Oral Ketoconazole -- Withdrawal and Recall
  • Buflomedil -- Suspension and Recall from the Egyptian Market
  • Kava-Kava-- Withdrawal and Recall
  • Celecoxib -- Removal of (FAP) indication
  • Update to ongoing safety review of Pioglitazone and increased risk of bladder cancer
  • Angiotensin Receptor Blockers (ARBs): FDA has completed drug Safety Review 

8 - 2011
  • High dose Simvastatin-- New restrictions and Safety recommendations 
  • Drospirenone -- Possible increased risk of blood clots
  • 5-alpha reductase inhibitors (5-ARIs) -- Increased Risk of Prostate Cancer
  • Champix-- Risk of Certain Cardiovascular Adverse Events

9 - 2011
  • Pioglitazone-- New contra-indications and warnings to reduce the risk of bladder cancer 
  • Oral osteoporosis drugs (bisphosphonates) – Conflict about  esophageal cancer risk.
  • Valproate Products-- Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)

10 - 2011
  • Linezolid -- Possible serious CNS reactions when given to patients taking certain psychiatric medications
  • Fluconazole-- Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects
  • Recombinant Human Growth Hormone (Somatropin)-- possible increased risk of death
  • Warning on Body Building Products Marketed as Containing Steroids or Steroid-Like Substances

11 - 2011
  • Risks associated with Intravitreal Off label use of Avastin
  • Herceptin -- Batch Counterfeit in Egypt
  • Avara (leflunomide)-- New warnings are added to the insert leaflet
  • Metoclopramide--Stronger warnings on risk of abnormal muscle movements

12 - 2011
  • Buflomedil-- European Medicines Agency recommends suspension of all dosage forms
  • Avastin-- Breast Cancer Indication Removal from the Label
  • Citalopram-- Abnormal heart rhythms associated with high doses