Warnings Added to Provigil Label

Warnings about the potential for serious rashes and psychiatric symptoms have been added to the prescribing information for the wakefulness-promoting agent Provigil (modafinil), the FDA has announced.

Although rare, serious rashes — including Stevens-Johnson syndrome, toxic epidermal necrolysis, and rash with eosinophilia and systemic symptoms — have been reported in children and adults on the drug. In addition, multiorgan hypersensitivity reactions have occurred.

Some patients also report experiencing anxiety, mania, hallucinations, and suicidality on the drug. Thus, "caution should be exercised when Provigil is given to patients with a history of psychosis, depression, or mania," the label states.

Finally, the label reminds providers that Provigil is not approved for use in children for any indication.