Announcement: “New Publication: Bulletin MADRAC - August 2016”

MADRAC Bulletin - August 2016

Annual Report for 2015
   ▪ Spontaneous Adverse Drug Reactions (ADRs) including Adverse Events Following Immunisation (AEFIs) Reported in Malaysia
Regulatory Matters
   ▪ Bisphosphonates: Risk of osteonecrosis of the external auditory canal.
   ▪ Minyak Cajeput (Melaleuca leucodendran): Risk of glottal spasm and bronchospasm.
   ▪ Glivec (imatinib) and Tasigna (nilotinib): Risk of Hepatitis B Virus reactivation.
   ▪ Adempas (riociguat): New contraindication for patients with pulmonary hypertension associated  with idiopathic interstitial pneumonia.
What’s New?
▪ Consumer Side Effect Reporting Form (ConSERF)