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Provigil (modafinil) Tablets - Warnings Added to Prescribing Information Regarding Serious Rash and Hypersensitivity Reactions, and Psychiatric Symptoms

BETHESDA, MD -- October 24, 2007 -- U.S. Food and Drug Administration (FDA) and Cephalon notified healthcare professionals of Warnings added to prescribing information for Provigil (modafinil).

Provigil is indicated to improve wakefulness in adult 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 (SJS) 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 postmarketing experience. Angioedema and multi-organ hypersensitivity reactions have also been reported in postmarketing experience.

Physicians should instruct their patients to immediately discontinue the use of Provigil and contact them if a rash or other hypersensitivity reaction occurs. Healthcare professionals and consumers should also be aware that Provigil is not approved for use in pediatric patients for any indication. In addition, psychiatric adverse experiences (including anxiety, mania, hallucinations, and suicidal ideation) have been reported in patients treated with Provigil. Caution should be exercised when Provigil is given to patients with a history of psychosis, depression, or mania.

Additional labeling revisions were made to the Clinical Pharmacology, Precautions, and Patient Package Insert sections.


SOURCE: U.S. Food and Drug Administration

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