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Accutane®-Exposed Pregnancies—California, 1999
Arch Dermatol. 2000;136:686-687.
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ACCUTANE®* (ROCHE Laboratories, Nutley, New Jersey), known by the generic name "isotretinoin," is a prescription oral medication approved by the Food and Drug Administration (FDA) to treat severe, recalcitrant nodular acne.1 It is also a known human teratogen that can cause multiple major malformations. Embryopathy associated with the mother's exposure to isotretinoin during the first trimester of pregnancy includes craniofacial, cardiac, thymic, and central nervous system malformations.2-3 In response to FDA recommendations,4 the manufacturer began a pregnancy-prevention program (PPP) in 1988 that included educational materials for physicians and patients and offered women reimbursement for contraceptive counseling by a physician. The PPP coordinators asked reproductive-aged women being treated with isotretinoin to enroll voluntarily in the Boston University Accutane Survey (BUAS).5 The total number of reproductive-aged women taking isotretinoin in the United States is unknown; however, 454,273 women enrolled in the BUAS from 1989 to October 1999. BUAS has estimated that 38%-40% . . . [Full Text of this Article]Summary of Interviews
Case Reports
Case 1 Case 2 Case 3 Reported by: CDC Editorial Note:
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