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NEW WARNING
Biogen Idec and Elan have issued a “Dear Healthcare Professional” letter to announce changes to the prescribing information for their monoclonal antibody natalizumab (Tysabri), used to treat multiple sclerosis. Postmarketing studies have led to changes in the Warnings section after reports of hepatic dysfunction and failure, sometimes fatal, in patients receiving the drug. They advise that patients have regular liver function tests and that use of the drug be stopped in anyone who develops jaundice or has laboratory reports that indicate hepatic injury. They have added information to the Patient Counseling section that alerts patients to the possibility of liver injury and advises them to contact their health care provider immediately if they have signs of liver dysfunction.
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