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 and GI, hepatology and pancreatic disorders
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  Haematology, Immunosuppression and transplantation, Infectious disease, Neurology, Obstetrics, gynaecology and fertility, Paediatrics and neonatology, and 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