January 20th, 2012
06:44 PM ET

MS drug Gilenya under safety review

Health agencies on both sides of the Atlantic are investigating reports of 11 deaths in multiple sclerosis patients taking Gilenya, the first multiple sclerosis drug approved in pill form. 

The U.S. Food and Drug Administration confirmed Friday that it is studying data on Gilenya (fingolimod).  "We will notify the public once our review is complete to communicate any recommendations or possible label changes," the FDA said in a statement to CNN.

The investigation comes on the heels of the European Medicines Agency  announcing, that they are reviewing the drug, after reports of several deaths from heart problems in patients.

Gilenya was approved for the treatment of relapsing-remitting multiple sclerosis in 2010.  The FDA recommends that before patients start on the drug, they are made aware of potential heart-rate problems.  The agency further recommends that patients only take Gilenya at their physician's office , where they are monitored for six hours after they take the first dose.

The Swiss pharmaceutical company Novartis says last November it was "notified of the first reported case of a patient death that occurred within 24 hours after receiving the first dose of Gilenya."  In a statement to CNN, the company says the cause of death remains unknown.  Ten more patients taking the medication have died, due to sudden death, heart attack or disruption of the heart rhythm, according to Novartis.  "As noted by EMA, it is currently not clear whether these deaths were caused by Gilenya or not," 

The company points out that in clinical trials, there was not an imbalance in deaths of patients on the drug and incidents in the general population.

The National Multiple Sclerosis Society notes that it unclear what role Gilenya may have played in these deaths and is waiting for the results of the investigation.  Dr. Timothy Coetzee, chief research officer for the National MS Society, says "understanding the benefits and risks of therapies is vitally important to everyone in the MS community."

In addition, the organization stresses the importance of the EMA's recommendation for heightened monitoring procedures after the first dose is administered.

The MS Society recommends patients currently taking this drug consult their doctor or contact the Novartis patient support line at 888-NOW-NOVA (888-669-6682) for more information.

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