Cephalon has notified healthcare professionals about new safety information for Provigil (modafinil). Provigil is used to reduce excessive sleepiness in adult patients with narcolepsy and other sleep disorders. Provigil is not approved for any indication in children.
The revised labeling warns that Provigil can cause life-threatening skin reactions, including Stevens-Johnson Syndrome (SJS). Although benign rashes can also occur with this drug, the company says that it is not possible to reliably predict which rashes will be serious. Because of this, Provigil should ordinarily be stopped at the first sign of a rash, unless the rash clearly is not related to the drug.
The labeling also warns that Provigil can cause other serious hypersensitivity reactions. If a multi-organ hypersensitivity reaction is suspected, the drug should be discontinued. Patients should be told to stop taking the drug if they develop signs or symptoms suggesting angioedema or anaphylaxis.
Provigil can also cause psychiatric symptoms, including anxiety, mania, hallucinations and suicidal ideation. The company advises caution when the drug is given to patients with a history of psychosis, depression or mania. If psychiatric symptoms develop, consider discontinuing the drug.
FDA Patient Safety News: January 2008
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Author: USFoodandDrugAdmin
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