The Food and Drug Administration has issued a formal warning about risks posed by the revolutionary multiple sclerosis (MS) drug Gilenya, especially to patients with pre-existing heart conditions.
According to a HealthDay News report, the agency issued an alert earlier this week urging physicians to avoid prescribing Gilenya, the first pill-form drug in the treatment of MS, to patients with pre-existing heart maladies, those who’ve suffered a stroke, or those who are taking other medications that control their heart rhythm.
The FDA initiated a review of Gilenya after receiving a report of a patient who died 24 hours within taking their first dose of the drug. Further reviewing by the agency revealed results of clinical trials and reports of other adverse reactions suffered by patients taking Gilenya, including several reports of deaths tied to heart conditions.
The agency stopped short of blaming Gilenya exclusively for those deaths, including the one that prompted the review and this week’s alert, but did indicate the drug seems to have a significant impact on a patient’s heart within the first day of the first dose. Doctors prescribing Gilenya to MS patients are encouraged to monitor them for six hours after dispensing the drug. This warning was also included in the FDA’s most recent announcement but had been suggested in the past.
Gilenya is believed to affect the heart rate by slowing it to fatal lows and this effect typically happens within the first 20 hours of taking the drug.