The federal authorities sent a letter to doctors warning that the government has received reports of life-threatening rashes and hallucinations in patients taking Provigil.
Provigil is indicated to improve wakefulness in adult with narcolepsy; obstructive sleep apnea/hypopnea syndrome and shift-work sleep disorder. The drug received a federal approval in 1998 for patients with narcolepsy, a neurological disorder that causes people to fall asleep at random times.
Other negative side effects have included instances of Stevens-Johnson Syndrome, begins as a red rash but can eventually cause skin to peel off the body, resulting in deadly infections.
The Associated Press reports that nearly all cases of the disorder occurred within five weeks of patients starting therapy with Provigil. FDA advised doctors to immediately discontinue using Provigil immediately after the first sign of any rash.
Doctors are also advised to exercise caution when giving the drug to patients who have a history of psychosis, depression, mania and suicidal thoughts. Psychological problems generally stopped within 36 hours of discontinuing use of Provigil.
Cephalon also warned doctors of misuse of its pain drug Fentora less than a month ago. Fentora is used to treat extreme pain in cancer patients.
