Modafinil (marketed as Provigil): Serious Skin ReactionsFDA has been monitoring cases of serious skin reactions, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), in its postmarketing reviews of adverse event reports associated with the use of modafinil. The product labeling for modafinil has been recently updated to include a bolded warning for serious rash, including SJS. Based on postmarketing data for modafinil, a recently approved drug with a similar chemical structure, armodafinil, includes a similar bolded warning in the product labeling. Healthcare professionals and patients should be watchful for skin reactions associated with the use of modafinil and armodafinil and report cases to FDA’s MedWatch.

From FDA Drug Safety Newsletter, Fall 2007.

Modafinil (sold as Provigil, which is targeted for prevention of certain sleep disorders) is often provided as an off-label prescription for the treatment of attention deficit disorder. In 2006, the FDA denied the Cephalon company’s request to approve modfinil (to be sold under the brand name Sparlon) as an ADHD treatment for children and adolescents. In denying the request, the FDA cited particular concern for the potential of SJS. Full article on Sparlon here at Marketwatch.

This entry was posted on Monday, October 8th, 2007 at 1:06 am and is filed under In the News, Reference -- Pharma, Meds, Drugs. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.