FDA Puts New Limits on Multiple Sclerosis Drug, Gilenya
May 14th, 2012 tmccoy
The FDA has finished evaluating a report on a patient who died after taking a single dose of Gilenya (fingolimod), a multiple sclerosis drug. The agency also has evaluated additional clinical trial and post market data for Gilenya, which it found to include several reports of patients who died of cardiovascular events or unknown causes while taking Gilenya. In their research, the FDA did not conclude that Gilenya was related to any of those deaths.
However, based on its reevaluation of the previously examined data, FDA is concerned about the cardiovascular effects of Gilenya after patients take it for the first time. According to the collected data, the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose but the maximum effect may occur as late as 20 hours in a small percentage of patients.
For this reason, FDA advises against its use of Gilenya in patients with certain pre-existing or recent heart conditions or stroke, or who are taking particular antiarrhythmic medications. By recent, the FDA means that you have suffered one of these events in the last six months.
Source: The Division of Drug Information (DDI), FDA
