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June 10, 1988

FDA Ponders Approaches to Curbing Adverse Effects of Drug Used Against Cystic Acne

JAMA. 1988;259(22):3225. doi:10.1001/jama.1988.03720220003003

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MORE INTENSIVE EFFORTS to avoid pregnancies in patients being treated with isotretinoin (Accutane) are coming.

A dermatologic drugs advisory committee to the Food and Drug Administration (FDA) has, among other things, recommended unanimously that the drug be allowed to remain on the market with revised labeling.

Frank E. Young, MD, FDA commissioner, said the agency would move quickly to evaluate the committee's recommendations and to carry out those that would have the greatest impact on curbing the serious side effects associated with the drug.

Ever since it was approved for cystic acne (JAMA 1982;247:1800-1801), the drug has been contraindicated in women who are pregnant or unwilling to prevent pregnancy while under treatment. Despite the warnings, fetal malformations have occurred. To date, 62 birth defects attributed to the drug have been reported.

Extrapolating nationwide from data obtained among Medicaid patients in Michigan and the Group Health Cooperative in Seattle, FDA scientists