Drug Safety Update Volume 9, Issue 9, April 2016

Medicines and Healthcare products Regulatory Agency

MHRA, 17 de abril de 2016

Contenido

· SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis

· Natalizumab (Tysabri ▼): progressive multifocal leukoencephalopathy—updated advice to support early detection

· Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy

· Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections

· Apomorphine with domperidone: minimising risk of cardiac side effects

· Aflibercept (Zaltrap▼): minimising the risk of osteonecrosis of the jaw

· Live attenuated vaccines: avoid use in those who are clinically immunosuppressed

· Meprobamate: licence to be cancelled

· Paraffin-based skin emollients on dressings or clothing: fire risk

· Letters sent to healthcare professionals in March 2016