Provigil Dangers Drug Safety Legal Information

Provigil Recall
PROVIGIL remains the first and only FDA-approved medication to promote wakefulness. It is prescribed for excessive sleepiness associated with serious medical conditions affecting millions of people. PROVIGIL has generated nearly 10 million prescriptions and over $2 billion in cumulative revenue since its U.S. launch in 1999.

The Fall 2007 issue of the FDA Drug Safety newsletter notes: "FDA has been monitoring cases of serious skin reactions, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), in its post marketing reviews of adverse event reports associated with the use of modafinil." The labeling on Provigil was recently updated to include a warning about serious skin rash as a side effect.

A serious rash or serious allergic reaction
- Especially including SJS or TEN
- Including rash, hives, sores in the mouth or skin, blisters and peels, swelling of the face, eyes, lips, tongue, or throat, trouble swallowing or breathing and hoarse voice.

Mental (psychotic/psychiatric) symptoms.
- Such as suicidal ideations or suicide attempts.

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Additional Notes :

Brent Coon & Associates is one of the largest trial law firms in the
nation and the epitome of the 21st century law practice.
Brent Coon & Associates employs aggressive litigators, with solid experience in individual and complex multi-party, pharmaceutical product liability litigation. The firm serves as lead counsel to numerous legal matters, including the BP Texas City Explosion. For his efforts, Brent Coon received the Steven J. Sharp Award (national trial lawyer of the year) from the American Association of Justice, the Clarence Darrow Award, and the USMFW Humanitarian Award and was named one of Texas' Super Lawyers for 2007.

Michael Hugo is our managing attorney in the recently opened Boston office. Mike has been active in the litigation of the most high profile pharmaceutical cases in the nation. He has also has lectured on pharmaceutical litigation and is head of the BCA committee on dangerous drugs.