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MHRA Drug Safety Update April 2017

MHRA Drug Safety Update April 2017

Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures

Babies born to mothers who take valproate medicines (Epilim▼, Depakote▼) during pregnancy have a 30–40% risk of developmental disability and a 10% risk of birth defects.

Prescribers should consider reducing the dose of ponatinib to 15 mg a day for patients with chronic phase chronic myeloid leukaemia (CP-CML) who have achieved a major cytogenetic response.Ponatinib (Iclusig▼): risk of vascular occlusive events—updated advice on possible dose reduction

Healthcare professionals should report any suspected adverse effects relating to fingolimod (Gilenya▼) or other treatments for multiple sclerosis, including suspected adverse effects occurring after discontinuation, via the Yellow Card Scheme.Multiple sclerosis therapies: signal of rebound effect after stopping or switching therapy

Letters sent to healthcare professionals in March 2017

A summary of letters sent to relevant healthcare professionals.

  • Nulojix (belatacept) 250 mg: supply shortage—restricted to existing patients
  • Mucodyne Paediatric Syrup 250 mg/5 mL (carbocisteine oral liquid): new double-strength presentation—check dose volume to ensure appropriate dose is given (from October 2016)

Drug Safety Update is a monthly newsletter from the Medicines and Healthcare products Regulatory Agency (MHRA) and its independent advisor the Commission on Human Medicines.

Drug Safety Update Volume 10, Issue 9