Reacting to a death associated with the multiple sclerosis drug fingolimod (Gilenya), the FDA said patients with certain cardiac risk factors should not take the oral agent.
The death was reported last year and the agency had promised to investigate it.
In an announcement on Monday, the FDA said it still didn't know whether fingolimod caused the patient's death, but nevertheless it was adding new contraindications to the drug's label, as well as a beefed-up recommendation for monitoring patients after dosing.
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Source: MedPage Today