Provogil Attorneys

Provigil (modafinil) is a central nervous system stimulant medication approved by the US Food and Drug Administration (FDA) in 1998 for the treatment of narcolepsy, excessive daytime sleepiness related to obstructive sleep apnea, shift work sleep disorder. Cephalon Inc makes and markets the drug.

As of June 2009, Provigil is among 20 medications undergoing a FDA safety review. The FDA issues the list of medications on a quarterly basis in its “ongoing effort to inform the public about early investigations of potential side effects that have been reported”. Provigil was included in the list for serious skin reactions that were identified as an issue with the drug in 2007.

In October 2007, the FDA had in fact asked Cephalon to add warnings on Provigil’s label about a risk for life-threatening skin rashes and psychiatric problems. This was followed in November of the same year by a request by the FDA to strengthen the warning on the drug’s label that the drug is not approved for use in children under the age of 16. The FDA had received multiple reports, including those involving:

• allergic reactions known as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
• Drug Rash with Eosinophilia and Systemic Symptoms
• Angioedema
• psychiatric symptoms including in children, and including severe reactions such as anxiety, hallucinations, mania, and suicidal thoughts

Then in September 2008, Cephalon reached a settlement in a case ensuing from federal charges that it had illegally marketed Provigil and two other drugs. The charges included those that Cephalon had promoted Provigil for unapproved uses, including for the treatment of fatigue. The drug maker ended up paying a fine of $425 million and pleading guilty to a criminal misdemeanor for the illegal off-label marketing of Provigil.

More recently, in March 2009, Provigil was found to be potentially addictive when used to enhance brain performance, an off-label use. Dr. Nora Volkow, director of the National Institute on Drug Abuse, noted "The main problems that we see, are not the people who are properly prescribed the medication, but individuals who may be misusing and abusing the medication."

For now, it should be underscored that off-label use of Provigil, including that in children under 16 years of age, carries an unwarranted risk for injury. Patients legitimately taking the drug should immediately stop taking it and contact their physician if they experience any swelling of the face, lips, eyes, tongue, larynx, difficulty breathing or swallowing, hoarseness, or psychiatric symptoms.

If you or a loved one has suffered any side effects associated with the use of Provigil, you may be entitled to compensation. Contact a qualified and experienced pharmaceutical injury attorney for an evaluation of your case.