Regulatory Focus™ > News Articles > FDA Issues New Recommendations for MS Drug After Cardiovascular Concerns Raised

FDA Issues New Recommendations for MS Drug After Cardiovascular Concerns Raised

Posted 14 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has placed new contraindications on Novartis' Multiple Sclerosis drug Gilenya (fingolimod) after investigating the cases of several patients who died soon after taking the drug.

FDA said it had completed an investigation into the adverse event reports, and while it "could not definitely conclude that Gilenya was related to any of the deaths," it remained "concerned about the cardiovascular effects of Gilenya after the first dose."

Its primary concern is related to the time at which Gilenya's maximum dose comes into effect in a patient. FDA said data showed most patients experienced this effect within six hours of taking the first dose of Gilenya, but some patients could experience this up to 20 hours after the first dose.

To prevent patients from possibly suffering adverse events outside of a monitored medical setting, FDA said it was making numerous recommendations to physicians prescribing Gilenya to their patients.

In addition to recommending physicians monitor patients taking Gilenya for a slow heartbeat, FDA said it wants physicians to take an hourly blood pressure and pulse reading and conduct an electrocardiogram test prior to providing a patient with an initial dose.

FDA also said it recommends cardiovascular monitoring be extended past six hours after the first dose for patients "who are at higher risk for or who may not tolerate" a slowdown in the rate at which their heart beats (bradycardia).

Read more:

FDA - FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)

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