Cephalon’s Provigil reported to cause life-threatening Skin rash and Psychiatric symptoms. US Food and Drug Administration (FDA) added this new warning to this sleep drug. Provigil is used for Obstructive sleep apnea, shift-work sleep disorder and Narcolepsy. Provigil is prescribed to improve wakefulness in those patients. FDA advised doctors not to prescribe this drug to patients with a history of depression or mania as Provigil causes hallucinations or suicidal thoughts in them. FDA approved Provigil in 1998 for use in adult patients.
Side effects of Provigil:
Most of these side-effects occur within 5 weeks of Provigil therapy. Psychological symptoms will stop within 3 days of stopping the drug.
1. Serious skin rashes like Stevens – Johnson syndrome, Toxic Epidermal Necrolysis and Eosinophilia.
2. Psychiatric symptoms like anxiety, mania, hallucinations and suicidal tendency.
3. Angiodema.
4. Multi-organ hypersensitivity reactions.
Patients should immediately stop the drug if they find any of the above symptoms and consult doctor. Provigil is not approved for use in Pediatric patients. This is another major blow for Cephalon after Fentora (Cancer drug) issue.
Source: FDA (Food and Drug Administration).
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