FDA warns of Provigil risks

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

Suggested Articles

While Lilly's 2018 launch Emgality is approved to prevent migraines, Reyvow is intended to treat them as they occur.

ICER's new draft review of RA drugs takes a different approach, reflecting how physicians treat the disease and the time horizon that's considered.

Johnson & Johnson is facing multibillion-dollar liabilities in thousands of talc and opioid cases. But that's not such a bad thing, one analyst said.