FDA strengthens Gilenya safety warnings

The FDA has said that MS drug Gilenya (fingolimod) should not be used in patients with a recent history of stroke or heart disease.

The requested label change adds to changes requested by the EMA and the FDA in April to reduce the risk of cardiovascular and neurovascular events.

The FDA also concluded that a number of sudden deaths in patients with severe MS taking Gilenya could not be conclusively linked to the drug.

Gilenya was recommended by NICE in late April as a “valuable new therapy” for severe relapsing-remitting MS.

The new FDA safety review reinforced the earlier recommendation that doctors monitor the heart rate of patients taking Gilenya for the first time.

However, it said that the death of a 59-year-old patient in November after a first dose of Gilenya could have been caused by the patient’s advanced brainstem MS lesions and not by the drug.

In other cases of sudden death in patients taking Gilenya, it said, the drug’s “contribution to the death was unclear”.

However, the FDA definitely recommended not using Gilenya in patients who have suffered a stroke or heart disease within the previous six months, or who are taking certain medications for cardiac arrhythmia.

Gilenya was approved in the US in 2010 and in the EU in 2011, and remains the only oral MS drug on the market.