Cephalon Added Warning To Provigil Label About Serious Skin Reactions In August 2007
October 24th, 2007 Posted by: Dr. Cox
A “Dear Doctor” Letter About Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated With Provigil Was Sent In September 2007
(Posted by Tom Lamb at DrugInjuryWatch.com)
On October 24, 2007 the FDA sent an email alert to inform doctors and other Men’s healthcare providers that the drug company Cephalon issued a revised package insert, or label, for Provigil (modafinil) in August 2007.
According to this October 2007 FDA alert about Provigil:
Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder….