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Isotretinoin

Posted Wednesday 17 February 2010 - 15:40 PM by David Chan (MEDIUM significance )

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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