The agency, which approved the drug in 1998, says there were 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. Nearly all cases of the disorder occurred within five weeks of patients starting therapy with Provigil. The agency also cautioned doctors that reports of hallucinations, anxiety and suicidal thoughts have been reported with Provigil. Psychological problems generally stopped within 36 hours of discontinuing use.
The labeling change announcement comes less than one months after FDA issued a warning on another Cephalon drug, Fentora, which is a used to treat extreme pain in cancer patients. FDA said several patients had accidentally overdosed on the drug while using it for non approved uses.