A survey of pregnant women using isotretinoin

BACKGROUND Isotretinoin is a known human teratogen, causing birth defects and/or subnormal cognitive performance in prenatally‐exposed children. METHODS A survey was conducted among women who called teratology information services throughout North America. Using a structured questionnaire, women with an isotretinoin‐exposed pregnancy were prospectively interviewed before the outcome of the pregnancy was known. RESULTS Almost 1/4 of the women surveyed (24%; 8/34) did not recall having contraception counseling before starting their medications. Once therapy was initiated, 62% (21/34) recalled using a birth control method, but only 29% (6/21) recalled using 2 forms of birth control, as specified by the voluntary pregnancy prevention programs. Monthly pregnancy tests were not always conducted during treatment, as recalled by the surveyed women (56%; 19/34). As many as 24% (8/34) of the women surveyed recalled that they were not screened using 2 pregnancy tests before receiving a prescription, another recommendation of the programs. Only a small number of the women (30%; 6/20) in the United States recalled being enrolled in any manufacturers' voluntary pregnancy prevention survey. CONCLUSIONS Results demonstrate that essential components of voluntary pregnancy prevention programs were not consistently followed, which resulted in fetal exposures. Birth Defects Research (Part A), 2005. © 2005 Wiley‐Liss, Inc.