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Modafinil (Marketed as Provigil): Serious Skin Reactions Reported

The FDA 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 the FDA's MedWatch.