Isotretinoin
Isotretinoin
ATC Code: D10BA01
Warning
Based on a review of the Roche global safety database (as of November 6, 2009), 66 cases of severe skin reactions (e.g. erythema multiforme [EM], Stevens-Johnson syndrome [SJS], and toxic epidermal necrolysis [TEN]) in adults and children have been reported worldwide in association with ACCUTANE. Two of the cases were fatal. While there are confounding factors for the majority of the reports received, a causal association between ACCUTANE and these severe skin reactions cannot be excluded.
Evidence
Fair
Reference
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