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Birth Defects Caused by Isotretinoin New Jersey

Between June 1983 and January 1987, four infants with isotretinoin embryopathy were born in New Jersey. Isotretinoin embryopathy consists of severe birth defects associated with first-trimester exposure to the synthetic retinoid isotretinoin (Accutane TM*, Roche Laboratories, A Division of Hoffmann-La Roche, Inc.), which is used to treat severe, recalcitrant cystic acne. Two of the cases were reported to the New Jersey Birth Defects Registry. A third case was described in the pediatric literature (1). The fourth was identified through a teratologist currently investigating cases of isotretinoin embryopathy in the United States (Massachusetts General Hospital, unpublished data). These cases are similar to a larger number of cases that have been reported to the Food and Drug Administration (FDA) from all areas of the United States.

Case 1: In June 1983, a 1,260 g female infant of 30 weeks gestation was born to a 22-year-old woman with no previous pregnancies. The woman had taken isotretinoin for 8 days when she was 4 to 6 weeks pregnant. Isotretinoin treatment had been stopped when the woman learned that she was pregnant. At birth, the infant had microcephaly, bilateral microphthalmia, and bilateral rudimentary pinnae. She died on the 28th day of life. Postmortem examination revealed lissencephaly, rudimentary pinnae, atrial septal defect, ventricular septal defect, patent ductus arteriosus, and interrupted aortic arch (1).

Case 2: In June 1985, a full-term male infant weighing 2,760 g was born to a 22-year-old woman who had taken isotretinoin during the first weeks of gestation. She had been counseled about the risk of drug-induced birth defects and had elected to carry the pregnancy to term. The infant had micrognathia, facial dysmorphism, missing ear lobes, Dandy-Walker malformation, and hearing and visual impairment. He now has severe mental retardation and developmental delay and requires institutional care.

Case 3: In September 1986, a male infant of 27 weeks gestation was born to a woman who had taken isotretinoin during the second month of gestation. The infant had dysplastic external ears and hydrocephalus, which was treated with a ventriculoperitoneal shunt. This abnormality is thought to be secondary to an intraventricular hemorrhage during the early neonatal period.

Case 4: In January 1987, a full-term male infant weighing 3,558 g was born with dysplastic ears and hearing loss. His mother had been treated with isotretinoin during the first trimester of pregnancy.

Reported by: M Knapp, MSN, RN, Special Child Health Svcs and New Jersey Birth Defects Registry; New Jersey State Dept of Health. Birth Defects and Genetic Diseases Br, Div of Birth Defects and Developmental Disabilities, Center for Environmental Health and Injury Control, CDC.

Editorial Note: Isotretinoin was recognized as an animal teratogen before it was first marketed in September 1982. It was, therefore, classified by FDA as Category X, contraindicated for use during pregnancy. A statement to that effect was included in the package insert.

*Use of trade names is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services or the Public Health Service.

Birth Defects - Continued

In June 1983, human teratogenicity was reported to FDA and to the public (2). Subsequent reports have documented a strong association between a characteristic group of birth defects and exposure to isotretinoin during the first weeks of gestation (3,4). These defects include external ear malformations, cleft palate, micrognathia, conotruncal heart defects, ventricular septal defects, aortic-arch malformations, and certain brain malformations (3). In one prospective follow-up study, eight of 36 pregnancies that were exposed to isotretinoin resulted in spontaneous abortions during the first trimester; four resulted in live-born infants with at least one major malformation; one, in a malformed stillborn infant; and 23, in infants without major malformations (3). This study found a relative risk of 25.6 (95% confidence interval, 11.4 to 57.5) for the defects associated with isotretinoin embryopathy.

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TABLE II. Notifiable diseases of low frequency, United States

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*Four of the 57 reported cases for this week were imported from a foreign country or can be directly traceable to a known internationally imported case within two generations.

TABLE III. Cases of specified notifiable diseases, United States, weeks ending
March 19, 1988 and March 21, 1987 (11th Week)

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TABLE III. (Cont'd.) Cases of specified notifiable diseases, United States, weeks ending March 19, 1988 and March 21, 1987 (11th Week)

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TABLE III. (Cont'd.) Cases of specified notifiable diseases, United States, weeks ending March 19, 1988 and March 21, 1987 (11th Week)

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