The FDA and Cephalon advised healthcare professionals of warnings added to the prescribing information for Provigil, a drug used to improve wakefulness in patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder.
The revised prescribing information updates safety information to include warnings regarding serious rash, including Stevens-Johnson Syndrome, and hypersensitivity reactions and psychiatric symptoms.
Rare cases of serious or life-threatening rash have been reported in adults and children worldwide. Psychiatric adverse experiences also have been reported in patients treated with Provigil, the FDA said.
Provigil is not approved for use in pediatric patients for any indication.