Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers

Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place.

Xofigo▼ (radium-223-dichloride): new restrictions on use due to increased risk of fracture and trend for increased mortality seen in clinical trial

Now only authorised for use in patients with symptomatic bone metastases and no known visceral metastases who have had 2 previous systemic treatments for metastatic castration-resistant prostate cancer or who cannot receive other systemic treatments.

Daclizumab beta (Zinbryta▼): risk of immune-mediated encephalitis – some cases several months after stopping treatment

Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab.

Nusinersen (Spinraza▼): reports of communicating hydrocephalus; discuss symptoms with patients and carers and investigate urgently

Advise patients and their caregivers to seek urgent medical attention if any signs or symptoms of communicating hydrocephalus develop during nusinersen therapy for spinal muscular atrophy.

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).

Posted on the UK MHRA website on 25 September 2018