It’s no news that isotretinoin, the most effective treatment for severe or recalcitrant acne, is a potent teratogen. From its release as Accutane by Hoffman-LaRoche in 1982, isotretinoin had been classified as a pregnancy category X drug, defined as a drug with positive evidence of human fetal risk, where the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. Risk management at the time of initial approval was limited to labeling, which described the risk of teratogenicity in the package insert and the patient information brochure. In relatively short order, it was clear that such labeling was not enough to reduce the risk of fetal exposure to isotretinoin.
Altman EM. Isotretinoin and Pregnancy Prevention: Do We Need to Take a Long, Hard Look at Ourselves? JAMA Dermatol. 2014;150(4):361–362. doi:10.1001/jamadermatol.2013.6973
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