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April 25, 2001

Isotretinoin and Pregnancy

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;285(16):2079-2081. doi:10.1001/jama.285.16.2079-a

To the Editor: Since 1983, when the teratogenicity of isotretinoin was first documented in humans,1 the Dermatologic and Ophthalmic Drugs Advisory Committee of the US Food and Drug Administration (FDA) has met frequently to make recommendations to balance the needs of patients with severe cystic acne to receive isotretinoin with the need to protect fetuses from exposure.2 Central to these efforts has been a sponsor-developed pregnancy prevention program (PPP). Unfortunately there has been suboptimal participation in the PPP, and noncompliance with aspects of the program has been documented.2 Most importantly, pregnancies have continued to occur in women receiving this drug. In fact, since the drug was approved in 1982, the sponsor has documented 1995 isotretinoin-exposed pregnancies–clearly this is an underrepresentation of the total number of exposed pregnancies as the enrollment in the PPP has been low.2 On September 18, 2000, the FDA's Advisory Committee recommended new restrictions on prescribing and dispensing of isotretinoin that included the following: