Pregnancy outcomes and factors associated with voluntary pregnancy termination in women who had been treated for acne with isotretinoin

Clin Toxicol (Phila). 2012 Dec;50(10):896-901. doi: 10.3109/15563650.2012.739287. Epub 2012 Nov 1.

Abstract

Objective: We aimed to study the pregnancy outcomes of women exposed to isotretinoin and to identify the factors influencing their decision to request an abortion.

Methods: The study prospectively identified 79 women who had been treated for acne with isotretinoin during the periconceptional period, and who were followed up until completion of their pregnancy. Characteristics of exposure and doses were self-reported by participants.

Results: Of the 56 participants who decided to continue their pregnancy, there were 11 spontaneous abortions and 44 women who delivered healthy full-term babies of which 19 had been exposed to isotretinoin <1 month before conception or during pregnancy. In a nominal logistic regression analysis including 68 patients who provided adequate information for analysis, exposure to isotretinoin >2 weeks post-conception and pregnancy termination recommended by the first-contact physician were found to be significantly associated with patients' decision to undergo elective abortion: adjusted OR = 9.87 (95% CI 1.18-82.34) and 12.51 (95% CI 2.36-66.29), respectively.

Conclusions: Our study reports an elevated rate of babies born without evidence of gross malformation or neurofunctional abnormality even tough exposure occurred during the teratogenic risk period. However, caution is recommended since a substantial risk of congenital malformations has been reported with low doses of isotretinoin and at exposures limited to early pregnancy. We also found that primary-care physicians may influence patients' decision to request pregnancy termination independently of their timing of exposure to isotretinoin.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology*
  • Abortion, Eugenic*
  • Acne Vulgaris / drug therapy*
  • Adult
  • Dermatologic Agents / adverse effects*
  • Dermatologic Agents / classification
  • Female
  • Humans
  • Infant, Newborn
  • Isotretinoin / adverse effects
  • Live Birth / epidemiology*
  • Pregnancy
  • Prospective Studies
  • Republic of Korea / epidemiology
  • Teratogens / classification
  • Teratogens / toxicity*

Substances

  • Dermatologic Agents
  • Teratogens
  • Isotretinoin

Supplementary concepts

  • Accutane embryopathy