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NEW WARNING
Cephalon has issued a “Dear Healthcare Professional” letter about new warnings and safety information related to the CNS stimulant modafanil (Provigil). The new warning indicates that modafanil can cause life-threatening skin reactions and other serious hypersensitivity reactions. Stevens-Johnson syndrome has been associated with modafanil use. Patients should be told to stop taking the drug immediately if they have any rash or other signs of hypersensitivity reaction and to report the reaction to their health care provider. The letter also reminds providers that modafanil isn’t approved for use in children for any indication. The warnings in the prescribing information also include reports of psychiatric symptoms occurring in patients taking modafanil. These symptoms have included anxiety, mania, hallucinations, and suicidal ideations. Caution should be taken when prescribing modafanil to patients with a history of pyschosis, depression, or mania. Health care providers are asked to report any rash or hypersensitivity reaction to Cephalon at 1-800-896-5855.
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modafanil