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Drug Safety, the Sequel: This Time It's Specialist Products

Executive Summary

The withdrawal of Biogen Idec Inc. and Elan Corp.'s natalizumab (Tysabri) multiple sclerosis treatment just weeks after its introduction showed that specialist products aren't immune from serious safety issues. Sales and clinical trials of the drug were suspended with the cooperation of the FDA after two patients in the companies' clinical study of Tysabri in combination with Avonex developed the rare and often fatal demyelinating disorder PML.

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