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FDA Warns on Cephalon's Provigil

The sleep drug gets a new warning label due to serious side effects.

Updated from 5:36 p.m. EDT

The Food and Drug Administration posted a safety alert Wednesday on



sleep drug Provigil. The drugmaker last month said it would update the labeling to be in line with its Nuvigil, which was approved in June.

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Provigil is indicated to improve wakefulness in adult with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift-work sleep disorder. The FDA warned that there have been rare cases of serious or life-threatening rashes, angiodema and multi-organ hypersensitivity reactions and also psychiatric side effects such as anxiety, mania, hallucinations and suicidal ideation.

The revised warnings section of the prescribing information for Provigil and the updated safety labeling include warnings regarding serious rash and psychiatric symptoms. Health care professionals are advised to have patients immediately discontinue use if those symptoms occur, and also to exercise caution when giving the drug to patients who have a history of psychosis, depression or mania.

Cephalon also

warned doctors of misuse of its pain drug Fentora less than a month ago.

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