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Gilenya Subject to New Restrictions, Monitoring Recommendations

Filed May 15th, 2012 Laurie

On Monday, the Food and Drug Administration issued a safety announcement saying that the multiple sclerosis drug

Gilenya should not be given to patients with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to correct heart rhythm problems. The report comes after the agency received word that some patients had died within 24 hours of receiving their first dose.

Gilenya is prescribed to treat multiple sclerosis flare-ups and slow down the progression of the debilitating nervous system disorder.

The FDA said it could not be certain that Gilenya caused the deaths at this point, but it does have concerns about the cardiovascular effects after the first dose. The data analysis showed that the maximum heart rate-lowering effect of Gilenya usually occurs within six hours of taking the first dose; however, it can occur up to 20 hours later in patients.

The FDA recommends patients undergo electrocardiogram testing before they start taking the drug and at the end of the observation period. Cardiovascular monitoring should continue overnight in patients who have an elevated risk for, or may not tolerate, a slow heart rate.

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