A survey of pregnant women using isotretinoin

Birth Defects Res A Clin Mol Teratol. 2005 Nov;73(11):881-7. doi: 10.1002/bdra.20197.


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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Abnormalities, Drug-Induced / prevention & control
  • Adult
  • Contraception
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / adverse effects*
  • Female
  • Humans
  • Isotretinoin / administration & dosage
  • Isotretinoin / adverse effects*
  • Pregnancy
  • Pregnancy Tests
  • Surveys and Questionnaires
  • Teratogens / toxicity


  • Dermatologic Agents
  • Teratogens
  • Isotretinoin