FDA recommends keeping watchful eye on heart rates
MONDAY, May 14 (HealthDay News) -- Based on the report of a patient who died after taking one dose of the multiple sclerosis (MS) drug Gilenya (fingolimod) and on clinical trial data, the U.S. Food and Drug Administration is recommending extended monitoring for certain patients taking this drug, according to a May 14 Drug Safety Communication issued by the agency.
Although a cause of death was not identified, the patient in question, who also had extensive brainstem MS lesions, died within 24 hours of taking the drug. This prompted the agency to re-evaluate clinical trial data on the effects of the drug on heart rate and blood pressure.
The agency notes that Gilenya usually lowers a patient's heart rate within six hours of the first dose, but this effect can occur up to 12 to 20 hours after the first dose. Based on these findings, the FDA suggests monitoring patient heart rates longer than six hours if they experience a heart rate below 45 beats per minute, or if they have pre-existing conditions or take other drugs that could further slow heart rate.
According to the FDA, "in light of the findings of the clinical trial data and postmarketing data, including all reported deaths of cardiovascular or unknown origin, [we have] revised the Gilenya drug label with specific recommendations for monitoring patients and with new contraindications for use of Gilenya in certain patients."
More Information (http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm )