Gilenya Warning Updated By FDA Over Heart Risks

Federal health officials have updated the warnings for Gilenya, a multiple sclerosis (MS) drug manufactured by Novartis, to indicate that it should not be used by individuals who have recently suffered a stroke or who have certain heart conditions. 

In a drug safety communication issued on May 14, the FDA indicated that side effects of Gilenya on the heart may be dangerous or perhaps fatal in some cases.

The FDA launched an investigation into Gilenya late last year, after at least one patient died within 24 hours of taking the medication.

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Although the agency was unable to determine whether Gilenya played a role in the death, they have contraindicated Gilenya for patients with pre-existing heart conditions or heart problems that have occurred within the last six months, such as heart attacks, unstable angina, heart failure or decompensated heart failure that required hospitalization, among others. The FDA also contraindicated Gilenya’s use by patients who have suffered a stroke or who take Class Ia or Class III anti-arrhythmic drugs.

The FDA is also recommending extended heart monitoring in patients who are at higher risk for or who may not tolerate bradycardia.

Gilenya has been found to lower the heart rate when first taken, according to the FDA. The reduction in heart rate is biphasic, with the first happening within the first six hours. The second decrease occurs between 12 and 20 hours after that first dose, which the FDA believes to be tied to the body’s circadian rhythm.

While the FDA did not give the number of deaths linked to Gilenya use, it did note that the number due to heart problems did not appear to be higher than in MS patients who were not treated with Gilenya.

Gilenya (fingolimod) was approved by the FDA in 2010 as an oral treatment for relapsing forms of MS in adults. It is used to reduce how often flare-ups occur and to delay the onset of physical disability caused by MS.

Despite concerns over the safety of Gilenya when it was reviewed, the FDA agreed to fast-track the drug’s approval with minimal testing under a program aimed at getting crucial drugs to the market to address medication needs that have not been met by other drugs. It is the only oral MS drug on the market.

Prior to approval, the risk of some heart irregularities after the first dose were a concern, as side effects of Gilenya are known to include a decrease in heart rate and/or atrioventricular condition after the first does.  It is also known to increase the risks of vision loss and developing heart blocks or bradycardia when taken with some other drugs, including beta blockers and calcium channel blockers.


  • dr.imadSeptember 2, 2012 at 8:52 pm

    what is the required period of monitoring is it still 6hs is there any clear protocol for using the drug approved by FDA

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