Provigil – Risk for Skin Rash
Rare cases of life-threatening rash, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms have been reported in adults and children during worldwide postmarketing use of Provigil Generic.
The incidence of SJS and TEN exceeds the background rate (1 – 2 cases/million-person years) despite likely underreporting. Cases of angioedema and sometimes fatal multiorgan hypersensitivity reactions have also been reported.
Patients should be instructed to immediately discontinue therapy and contact their healthcare professional if a rash or other hypersensitivity reaction occurs, according to an alert sent from MedWatch, the FDA’s safety information and adverse event reporting program.
Reductil May Get Wider Approval
Provigil, sold under the name Provigil, was originally approved by the Food and Drug Administration in 1998 to treat narcolepsy, a serious condition in which people cannot stop falling asleep.
But since its introduction, the number of off-label prescriptions for Provigil has skyrocketed, with an estimated 80 percent of prescriptions for the drug going to night-shift workers, truck drivers, pilots and soldiers — jobs in which it’s crucial to remain awake and alert. Now the FDA may approve it for wider use — a move that has met with some controversy.
“In the ethical debate, it’s actually unethical for us not to help these patients,” said Dr. James Wyatt , a sleep disorders specialist at Rush-Presbyterian-St. Luke’s Medical Center in Chicago.
Provigil and treatment debilitating fatigue
Provigil may be a potentially effective treatment for primary biliary cirrhosis (PBC)-related fatigue. About 42 patients were given a 3-day trial of 100-200 mg Provigil. Response was defined as increased energy, decreased somnolence and sleep requirements, and improved daily function.
Patients with positive responses were continued indefinitely on the medication. During the initial trial period, 31 (73%) patients had complete response and continued to take the medication. Eleven (26%) had no response. In long-term follow-up (average 17.7 months), 25 (81%) patients continued to take 100-200 mg Provigil daily.