MS pill Gilenya undergoing safety review

Published date: 24 Jan 2012 at 1:16PM

The European Medicines Agency has begun a review of the 'benefits and risks' of the new MS pill Gilenya (aka fingolimod) following concerns over the treatment's effects on the heart after the first dose.

There have been reports of heart problems in people with MS, as well as the death of one patient in the United States, less than 24 hours after their first dose - although the exact cause of the patient's death is still unexplained.

In a statement released on 20 January the EMA report that, over the last eight years, a total of 11 people taking the treatment have died, but it isn't clear whether or not these deaths were related to Gilenya.

Gilenya was licensed in March for people with RRMS who have failed to respond to 'first line' treatments (like beta-interferon). To date more than 30,000 people have received the treatment worldwide.

We support the precautionary measure the EMA have taken to investigate the situation further, and we await the outcome of their review (due in March) before drawing any firm conclusions over the treatment.

As part of the review, the EMA has already recommended that doctors increase their level of monitoring of patients, including heart monitoring, after the first dose of the medicine.

All treatments carry risks, including those that have been around for some years. When considering any new treatment we would encourage people with MS to work with their consultant neurologist and other health professionals to make the right decision for them.

Page last updated: 14 Mar 2012

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