Provigil Side Effects include Stevens-Johnson Syndrome (SJS) Warns the FDA

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Provigil Side Effects include Stevens-Johnson Syndrome (SJS) Warns the FDA

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Provigil which is made by drug manufacturer Cephalon, is used to treat people suffering from narcolepsy and obstructive sleep apnea and stops them falling asleep at random times during the day.

The FDA says patients should stop using Provigil and see their doctor if they develop a skin rash or other hypersensitivity reaction.

According to government scientists negative side effects have included instances of Stevens-Johnson Syndrome, which begins as a red rash but can eventually cause skin to peel off the body, resulting in deadly infections.

Audience: Neuropsychiatric specialists, other healthcare professionals, consumers

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 labeling 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.

More Provigil news, information and resources at the: www.resource4defectivedrugs.com Providil page.