SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis

Test for raised ketones in patients with ketoacidosis symptoms, even if plasma glucose levels are near-normal.

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

Perform a quantitative serum anti-JCV antibody test—including index value—to support risk stratification for progressive multifocal leukoencephalopathy.

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

Cases of progressive multifocal leukoencephalopathy have been reported in patients taking dimethyl fumarate for multiple sclerosis, who all had prolonged lymphopenia.

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

The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.

Apomorphine with domperidone: minimising risk of cardiac side effects

Patients receiving apomorphine and domperidone require an assessment of cardiac risk factors and ECG monitoring to reduce the risk of serious arrhythmia related to QT-prolongation.

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

Dental examination and appropriate preventive dentistry should be considered before treatment, especially for patients also treated with an intravenous bisphosphonate.

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

Healthcare professionals working in primary and secondary care should ensure that clinically significant immunosuppression in a patient is identified before administration of a live attenuated vaccine.

Meprobamate: licence to be cancelled

Following an EU wide review of meprobamate, the remaining licence holder in the UK has ceased manufacturing and the licence will be cancelled by the end of 2016.

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

Smoking or a naked flame could cause patients’ dressings or clothing to catch fire when being treated with paraffin-based emollient that is in contact with the dressing or clothing.

Letters sent to healthcare professionals in March 2016

In March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.

Posted on the UK MHRA website on 18 April 2016