A popular narcolepsy drug has been linked with at least five different skin
diseases, according to the most recent FDA Drug Safety Newsletter.
The agency has been monitoring cases of serious skin reactions, including
erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal
necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms
(DRESS) in its postmarketing reviews of adverse event reports associated
with modafinil, known commercially as PROVIGIL.
Although some cases were potentially confounded by drugs known to be
associated with serious skin reactions, all cases had features that
implicate modafinil.
The product labeling for modafinil has been recently updated to include a
bolded warning for serious rash, including SJS.
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