FDA, Cephalon add warnings to Provigil

WASHINGTON The Food and Drug Administration as well as the manufacturer Cephalon has notified healthcare professionals that warnings have been added to the prescribing information for Provigil.

Provigil is used to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.

The new information includes warnings regarding serious rash, including Stevens-Johnson Syndrome and hypersensitivity reactions, and psychiatric symptoms. Rare cases of serious or life-threatening rash, including toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms have been reported in adults and children in worldwide post marketing experience. Angioedema and multi-organ hypersensitivity reactions have also been reported in post-marketing experience.