Provigil Linked to Serious Skin Reactions
The U.S. Food and Drug Administration and Cephalon, Inc. have added new warnings about dangerous side effects associated with the use of Provigil (modafinil).
Provigil is a prescription drug used to treat sleep disorders such as narcolepsy, obstructive sleep apnea, and shift work sleep disorder. The drug has been linked to severe, life-threatening skin rashes, including Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), Erythema Multiforme (EM), and Drug rash with Eosinophilia and Systemic Symptoms (DRESS). Stevens-Johnson Syndrome starts out as a painful red rash that can spread and blister, eventually causing the skin to peel off the body.
Provigil is also prescribed “off-label” to treat attention deficit hyperactivity disorder (ADHD) and depression. Off-label refers to use of a medication to treat symptoms other than what the drug is intended and approved for. Use of Provigil has also been associated with hallucinations, anxiety and suicidal thoughts.