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As many likely already are aware, Gilenya was approved by the FDA for use in the United States back in September 2010.  It is the first–and only–oral disease-modifying drug for multiple sclerosis.  Once thought to be something that would only exist in a futuristic world with flying cars and jet packs, an oral MS drug is a reality.

Unfortunately, it may also carry serious side effects.

Although Gilenya was approved by the FDA, the drug carries a warning that it could slow a patient’s heart beat when they start taking the medication.  The FDA guide indicates that, “your heart rate will usually slow down the most about six hours after you take the first dose,” but also notes that your slow heart rate should return to normal within one month of starting Gilenya.  The FDA also warns to contact a doctor if you experience dizziness, tiredness or a slow or irregular heartbeat.

Before taking the drug, then, it would be wise to inform a doctor of any previous heart problems you may have experienced.

And now the European Medicines Agency (EMA) – the European equivalent of the FDA – is recommending that doctors not prescribe the drug to patients with a history of cardiovascular and cerebrovascular disease or those taking heart-rate lowering medication.  The EMA also recommends that anyone considering taking Gilenya first have a doctor monitor their heart activity prior to starting the drug.  Their heart rate should also be closely watched immediately after taking the drug for the first time – the aforementioned six-hour window.

The Committee for Medicinal Products for Human Use – the division of the EMA that issued the new recommendations – closely examined 15 incidents of sudden or unexplained deaths in patients who took Gilenya.  The majority of these deaths were cardiovascular in nature but were not necessarily directly tied to the drug.

The bottom line is that Gilenya can be very beneficial to patients with multiple sclerosis, but its use needs to be closely monitored by a doctor.  Patients should have a heart monitor test before taking the drug and patients with a history of heart problems should avoid the Gilenya.


Rattue, Petra.  (27 April 2012).  Gilenya Heart Side Effects – European Medicine Agency Gives New Recommendations.  Medical News Today.  Retrieved from