The FDA Safety Information and Adverse Event Reporting Program have announced that the FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod).
Gilenya is an oral medication used to treat relapsing forms of Multiple Sclerosis (MS) in adults and is used to reduce the frequency of flare-ups and delay physical disability.
The FDA believes – as do most neurologists – that Gilenya provides an important health benefit when used as directed, and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label. The FDA recommends – obviously – that patients with MS not stop taking Gilenya without talking to their doctor.
The FDA is continuing to evaluate this case as they are not able to conclude whether the drug resulted in the patient’s death. The FDA will communicate any new information that results from this investigation.
I suspect Gilenya is a great drug. But the FDA is doing the right thing is taking adverse reports seriously with all drugs, particularly those that are new to the market.