Warnings Added to Prescribing Information

posted on:
November 26, 2007

author:
Staff

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.

Free Legal Consultation
At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.
back to top