Accutane (isotretinoin) Association with Cases of Severe Skin Reactions

Ottawa, ONHoffmann-La Roche Limited, in consultation with Health Canada, is informing prescribers and the public of important new safety information regarding the use of ACCUTANE® ROCHE ® (isotretinoin).

ACCUTANE is a retinoid indicated for the treatment of severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne.

There have been very rare post-marketing reports of severe skin reactions (e.g. erythema multiforme [EM], Stevens-Johnson syndrome [SJS],and toxic epidermal necrolysis [TEN]) associated with ACCUTANE use. These events may be serious and result in hospitalization, disability or death.

Over the past 25 years, ACCUTANE has been prescribed worldwide to approximately 16 million patients. 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.

The ACCUTANE Canadian Product Monograph will be updated with the above mentioned safety information.