Is Gilenya Safe to Treat MS?

Novartis drug Gilenya under safety review in EU and US

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) American and European health agencies are investigating the role of Gilenya, the first approved pill for treating multiple sclerosis.

It's not yet clear if the 11 reported deaths being reviewed were caused by Gilenya, but investigators are concerned that Gilenya may have a harmful effect on patients with heart problems.

"If you're taking Gilenya and have heart problems, talk to your doctor."

The first report of a death associated with Gilenya came at the end of November 2011. This patient died within 24 hours of the first dose of the drug. The cause is still unknown, according to Novartis, the maker of Gilenya.

Ten other deaths have been reported among patients taking Gilenya. Six of the deaths are from unexplained causes, three had heart attacks, and one died from disruption of heart rhythms, according to the European Medicines Agency.

The U.S. Food and Drug Administration is reviewing the safety data on Gilenya in order to possibly revise recommendations on the drug or make changes to the label. The review is expected to be complete in March 2012.

The European Medicines Agency recommends that doctors monitor their patient closely after the first dose is given, until new recommendations can be made.

Before treatment, patients should be monitored by an electrocardiogram, continuing 6 hours after the first dose. Blood pressure and heart rate should be measured each hour, and patients should be closely watched after 6 hours if they show any warning signs of slow heart rate.

Gilenya was approved in the US in 2010, and earned approval in Europe in March 2011. It's the first oral treatment for multiple sclerosis, a debilitating neurological disease that has no cure.

According to Novartis, 33,000 patients have taken the drug.

Reviewed by: 
Review Date: 
January 23, 2012
Last Updated:
January 24, 2012