Alerts
Modafanil (Provigil) - Rash and Psychiatric Warnings
10/25/2007
Cephalon updated warnings to the prescribing information of modafanil to include post-marketing adverse events reports for hypersensitivity reactions and psychiatric symptoms. The revised labeling will include warnings regarding hypersensitivity reactions and serious rash. Rare cases of life-threatening rash including drug rash with eosinophilia, Stevens-Johnson Syndrome, and toxic epidermal necrolysis have been reported in post-marketing experience in both adults and children. Multi-organ hypersensitivity and angioedema have also been reported. Psychiatric adverse events including anxiety, hallucinations, suicidal ideation, and mania have been reported with modafanil. Exercise caution when treating patients with a history of psychosis or depression with modafanil.
Instruct patients to immediately discontinue modafanil and contact their healthcare professional if hypersensitivity reactions or psychiatric symptoms occur. Healthcare professionals are encouraged to contact Cephalon’s Medical Services Department at 1-800-896-5855 to report cases of rash or potential hypersensitivity reactions.
Modafanil is not approved to treat pediatric patients for any indication.
Additional information is available at the following links:
- MedWatch Alert:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Provigil - Healthcare Professional Letter:
http://www.fda.gov/medwatch/safety/2007/Provigil_dhcpletter091207_final.pdf
