MADRAC Bulletin - December 2016

Regulatory Matters

▪ Olanzapine: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
▪ Codeine: Risk of respiratory depression
▪ Warfarin: Rare cases of calciphylaxis
▪ Advice on the risk of lower limb amputation during treatment with Invokana®(canagliflozin)
▪ List of Direct Healthcare Professional Communication (DHPC) letters for 2016

What’s New?

▪ Malaysian Pharmacovigilance Guidelines (2nd Edition)
▪ Vaccine Pharmacovigilance Guidelines (2nd Edition)
▪ Preparing for Pharmacovigilance Inspection