Letters sent to healthcare professionals in February 2018

Letters were sent about ellaOne, ERWINASE, Eperzan▼, Ocaliva▼, Velcade, Esmya, and Bleo-Kyowa.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 8 March 2018

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Endocrinology, diabetology and metabolism, GI, hepatology and pancreatic disorders, Haematology, Immunosuppression and transplantation, Infectious disease, Neurology, Obstetrics, gynaecology and fertility, Paediatrics and neonatology, Urology and nephrology

In February 2018, letters were sent to healthcare professionals about:

• ellaOne post-marketing surveillance: pregnancy registry
• Ocaliva▼ (obeticholic acid): reinforced differential dosing recommendations in primary biliary cholangitis (PBC) patients with moderate and severe hepatic impairment
• ERWINASE: vials from batch 186G* should be used with a 5-micron filter needle
• Bleo-Kyowa (bleomycin sulphate), powder for solution for injection – use 5-micron filter during IV infusion or pre-injection – see Class 4 Medicine Defect Information alert
• Velcade (bortezomib) 3.5 mg vials: potential defect of rotating and/or loose metal cap
• Restrictions on the use of ulipristal acetate, Esmya 5 mg tablet, and important new warnings of serious liver injury and recommendations for liver monitoring
• Eperzan▼(albiglutide): reminder letter regarding discontinuation

Article citation: Drug Safety Update volume 11 issue 8; March 2018: 5.

Published 8 March 2018