Fetal exposure to isotretinoin-an international problem

Reprod Toxicol. 2008 Jan;25(1):124-8. doi: 10.1016/j.reprotox.2007.10.005. Epub 2007 Oct 25.


Background: Isotretinoin is a known teratogen. Pregnancy prevention programs aimed at minimizing isotretinoin exposure in pregnancy have been implemented in North America with limited success.

Objective: To compare the management of fetal risk of isotretinoin in three countries, including information given to women, implementation of contraceptive methods, and pregnancy outcomes.

Methods: Pregnant women exposed to isotretinoin who called teratogen information services (TIS) in Israel, Italy and Canada between July 1998 and October 2006 were interviewed at the time of initial consultation and after the expected day of delivery.

Results: Fifty-three pregnant women exposed to isotretinoin contacted the TIS. Only 41% reported using a birth control method. Just one patient reported using two different forms. Forty-five percent of exposed pregnancies were terminated before delivery and 22% delivered healthy babies. Two babies were born with malformations.

Conclusions: Since isotretinoin-exposed pregnancies still occur, there is a need for more effective strategies, which should take into account the cultural differences.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abnormalities, Drug-Induced / etiology*
  • Abnormalities, Drug-Induced / prevention & control
  • Abortion, Therapeutic*
  • Adult
  • Canada
  • Contraception*
  • Dermatologic Agents / toxicity*
  • Drug Information Services*
  • Female
  • Fetus / drug effects*
  • Follow-Up Studies
  • Global Health
  • Guideline Adherence
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Infant, Newborn
  • Isotretinoin / toxicity*
  • Israel
  • Italy
  • Live Birth
  • Patient Education as Topic
  • Practice Guidelines as Topic
  • Pregnancy
  • Pregnancy Trimester, First
  • Surveys and Questionnaires
  • Teratogens*


  • Dermatologic Agents
  • Teratogens
  • Isotretinoin