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Gilenya Subject to New FDA Restrictions

May 15, 2012 | Parker Waichman LLP

The U.S. Food & Drug Administration (FDA) warned yesterday that Gilenya should not be used in some patients, including those with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to control abnormal heart rhythms.  The new Gilenya restrictions follow the FDA's launch of a safety review in December, after the agency learned of one death that occurred within a 24 hours of a patient receiving a first dose of Gilenya.

According to the FDA, it was unable to determine if that death or other fatalities reported in postmarket or in clinical trials were related to Gilenya.  However, the agency said it has concerns about the cardiovascular effects of the drug after the first dose. 

Bradycardia, or slow heart rate, is one of the known side effects of Gilenya.   The FDA said its safety review found that the heart rate lowering affects of Gilenya can occur within six hours of taking the first dose, as late as 20 hours after the first dose.  As such, the agency is recommending:

  • All patients starting Gilenya be monitored for signs of a slow heart rate (bradycardia) for at least 6 hours after the first dose.
  • Recommending hourly pulse and blood pressure measurement for all patients starting Gilenya. 
  • Electrocardiogram (ECG or EKG) testing should be performed prior to dosing and at the end of the observation period.
  • Cardiovascular monitoring should continue until any symptoms resolve, the FDA said.

The FDA also recommended that patients who develop severe bradycardia after the first Gilenya dose, bradycardia may be poorly tolerated, and certain other patient be monitored beyond 6 hours.


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