Letters and drug alerts sent to healthcare professionals in August 2018

Letters were sent about daclizumab beta (Zinbryta▼), alteplase (Actilyse), Esmya (ulipristal acetate), and Xofigo▼ (radium-223-dichloride). MHRA issued alerts and recalls for batches of Nutriflex Omega Special 2500 ml and Nutriflex Lipid Special 2500 ml.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 25 September 2018

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

In August 2018, the following letters were sent from marketing authorisation holders to healthcare professionals about the safety of medicines:

• Esmya (ulipristal acetate): new contraindication, requirements for liver monitoring and restricted indication

• Xofigo (radium-223-dichloride): new restrictions on use due to increased risk of fracture and trend for increased mortality

• Daclizumab beta (Zinbryta▼): Cases of immune-mediated encephalitis, including anti-NMDA receptor encephalitis, reported several months after discontinuation of treatment

• Alteplase (Actilyse) in acute ischaemic stroke: Important information on extension to use in adolescents (≥16 years) and request for data collection

In August 2018, MHRA issued the following Alerts and recalls for drugs:

• Nutriflex Omega Special 2500 ml: Company-led recall 20 August 2018 – B. Braun Medical Ltd are recalling specific batches of Nutriflex Omega Special 2500 ml as it has been identified that these may have an out of specification result in the glucose chamber at the end of their shelf life.

• Nutriflex Lipid Special without Electrolytes 2500 ml: Company-led recall 23 August 2018 – B. Braun Medical Ltd are recalling specific batches of Nutriflex Lipid Special without Electrolytes 2500 ml as it has been identified that these may have an out of specification result in the glucose chamber at the end of their shelf life

Published 25 September 2018