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FDA warns of Provigil risks

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The FDA slapped a new warning on Provigil, a drug for narcolepsy and other sleeping disorders made by Cephalon. The agency warned doctors of sensitivity reactions--including rare but potentially deadly Stevens-Johnson syndrome--and of psychiatric side effects like hallucination and suicidal thoughts.

Provigil is also approved for use against drowsiness in shift worker--and it's been used off-label by truckers, med students and other types who want to stay awake all night, or even two to three days at a time. One of its selling points? Few side effects.

- read the new warning from the FDA
- see this story from the Houston Chronicle
- read about off-label use in Wired

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FDA staffers question safety of Sparlon for ADHD. Report
Positive Phase III results for Cephalon's Treanda. Report
Cephalon takes heat for off-label narcotic promotion. Report

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Comments

Anyone aware of the PBMs blocking access to Provigil scripts? We've run into some trouble on that front with my office.

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