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FDA adds warning to Cephalon's Provigil sleep drug

www.reuters.com

A warning is being added to Cephalon Inc's drug Provigil for excessive sleepiness because of the risk of serious skin rash and psychiatric symptoms, the U.S. Food and Drug Administration said on Wednesday.

Provigil is used to treat adults with narcolepsy and obstructive sleep apnea who have difficulty staying awake. Provigil is one of Cephalon's biggest-selling products with global sales of $415 million in the first half of 2007.

The warning means patients should stop using Provigil and see their doctor if they develop a skin rash or other hypersensitivity reaction, the FDA and Cephalon said in a joint statement posted on the regulatory agency's Web site.

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