Letters sent to healthcare professionals in July 2017

Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 15 August 2017

• Therapeutic area: Cancer, Cardiovascular disease and lipidology, Haematology, Neurology, Ophthalmology, Paediatrics and neonatology

In July 2017, the following letters were sent to relevant healthcare professionals to inform them of updated safety information:

• Imbruvica▼(ibrutinib) and risk of hepatitis B reactivation: hepatitis B virus status to be established before initiating treatment
• Zinbryta▼ (daclizumab): restrictions of use of in view of fatal fulminant liver failure
• Aflibercept (Zaltrap▼) concentrate for solution for infusion 200 mg/8 mL: some batches contain previous Patient Information Leaflet; inform patients of warnings for heart failure
• Valproate medicines: only for use when no other treatment is effective or tolerated in girls, women of childbearing potential, and women who are pregnant or planning pregnancy; important actions required — letter for specialists, specialist nurses/midwives, and general practitioners and letter for pharmacists
• Shortage of Trisenox (arsenic trioxide, 1 mg/ml concentrate for solution for infusion): replacement with imported arsenic trioxide injection 1 mg/ml (Phenasen) during supply shortage — prescribers should refer responsibilities for off-label or unlicensed use of medicines

Article citation: Drug Safety Update volume 11 issue 1, August 2017: 4.

Published 15 August 2017