EMA Reviewing MS Drug Gilenya after 11 Deaths

Last month the FDA launched a probe to investigate the safety of Novartis’ multiple sclerosis drug Gilenya, after a patient died unexpectedly within 24 hours of taking the first dose of the medication. Today Europe’s equivalent to the FDA, the EMA, has announced that they are launching their own review of the drug after discovering 10 more deaths in patients taking Gilenya. See the PMLive article here.

Of the 11 known deaths, seven are unexplained, three were caused by heart attack and one was caused by a disruption to the heart rhythm.

Gilenya was approved by the FDA in September of 2010 to reduce relapses and disability progression in patients suffering from relapsing forms of multiple sclerosis. Last March Gilenya was approved for use in the both Canada and Europe.

While the review of the drug is ongoing, the EMA is advising physicians to monitor patients more closely during the first hours after starting the drug. The agency is calling for doctors to carry out electrocardiograms before beginning treatment and to continue running these test for the first six hours after the initial dose. Read teh EMA statement here.

Gilenya is known to cause a slowing of the heart rate or bradycardia, which becomes more common in patients who are also taking cardiac medications like beta blockers and calcium channel blockers. The American patient that died was known to have been taking medications from both of these classes.

Until recent concerns Gilenya has been well received in its short time on the market, with over 30,000 patients and over 291 million is sales worldwide.