The US FDA has received a report of a patient who died within 24 hours of receiving fingolimod [Gilenya].
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■ The US FDA has received a report of a patient who died within 24 hours of receiving fingolimod [Gilenya]. A postmarketing report was submitted to the FDA’s Adverse Events Reporting System (AERS) regarding a patient with multiple sclerosis (MS) who died within 24 hours of receiving a first dose of fingolimod. The patient was also being treated with metoprolol and amlodipine. The exact cause of death has not yet been established. It is unclear, at this time, whether taking fingolimod was associated with the patient’s death. The FDA is working closely with the drug’s manufacturer, Novartis Pharmaceuticals, to evaluate the report. FDA. FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod). Internet Document : 20 Dec 2011. Available from: URL: http:// 803065017 www.fda.gov
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Reactions 7 Jan 2012 No. 1383
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