(This story has been posted on The Wall Street Journal Online's Health Blog at http://blogs.wsj.com/health.)
The FDA says the only oral multiple-sclerosis drug on the market -- Novartis's Gilenya -- shouldn't be used in patients with a recent history of stroke or some heart problems.
As WSJ reports, a safety review of the treatment was prompted by a report in November of a 59-year-old patient dying in the U.S. less than a day after taking the first dose of the drug.
Although the agency said an exact cause of the patient's death couldn't be identified, it continues to recommend that doctors closely monitor the hearts of patients after they have been given the first dose of the drug because the treatment can lower a person's heart rate temporarily.
Patients who have had a stroke or heart trouble within the past six months shouldn't take the drug, the FDA says. It also shouldn't be used in patients taking some kinds of medicines to treat heart arrhythmias.
The FDA warning comes after Europe's drug regulator last month requested stronger safety warnings. The U.S. agency is currently reviewing another oral MS drug from Biogen Idec designed to work through a different mechanism than Gilenya.
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