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Provigil Warnings Added For Serious Skin Rashes, Psychiatric Problems

Oct 25, 2007 | Parker Waichman Alonso LLP

The Provigil label has been updated to include warnings about life-threatening skin rashes and psychiatric problems linked to the drug.  The Food & Drug Administration (FDA) asked Cephalon, Inc., the maker of Provigil, to add the warnings after it had received multiple reports of skin rashes, including a disorder called Stevens-Johnson Syndrome, and psychiatric symptoms occurring in people who took Provigil, including children.

Approved by the FDA in 1998, Provigil has been used to treat the excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.  The military sometimes uses Provigil to keep pilots and soldiers awake during combat situations, and the drug is known to enhance short-term memory. Provigil is also used off-label to treat other conditions such as “chemo brain”, a type of cognitive impairment that often affects cancer patients undergoing chemotherapy.

The new Provigil warnings say that the drug has been associated with a number of serious skin disorders, including Stevens-Johnson Syndrome, a sometimes life-threatening hypersensitivity complex affecting the skin and the mucous membrane. Provigil has also been linked to Toxic Epidermal Necrolysis, another life-threatening, and usually drug-induced, dermatological condition that is characterized by the detachment of the top layer of skin from the lower layers of the skin all over the body.   Other conditions linked to Provigil include Drug Rash with Eosinophilia and Systemic Symptoms, a severe, unexpected reaction to a drug, which affects several organ systems at the same time; and Angioedema, a swelling beneath the skin similar to hives.

The new Provigil label says that patients should stop using the medication at the first sign of a skin rash and contact their doctors immediately.  Patients who experience any swelling of the face, eyes, lips, tongue, larynx or experience difficulty swallowing or breathing, or suffer from hoarseness should also stop using Provigil.

In addition to the skin disorders, the FDA has warned that Provigil use has been connected to severe psychiatric symptoms, including anxiety, mania, hallucinations, and suicidal thoughts.   The new Provigil labeling cautions physicians against prescribing the drug to people with a history of mania or depression, and says that Provigil use should be halted if a patient develops any psychiatric symptoms.   

Finally, the label warns that Provigil has not been approved for use in children, which is an off-label use of the medication.  It is known that doctors prescribed Provigil for a number of off-label uses, including the treatment of Attention Deficit Hyperactivity Disorder, Multiple Sclerosis and depression.  It is estimated that as much as 90% of all Provigil prescriptions are written for off-label use. Such off-label use is not illegal, as doctors are free to prescribed approved drugs in any way they see fit.  However, drug companies are not allowed to market a medication based on off-label use.  In 2004, Cephalon was investigated for allegedly promoting off-label uses for Provigil.  The company has also been investigated for promoting its painkillers Fentora and Actiq in the same manner.