Pregnancy outcome following exposure to topical retinoids: a multicenter prospective study

J Clin Pharmacol. 2012 Dec;52(12):1844-51. doi: 10.1177/0091270011429566. Epub 2011 Dec 15.

Abstract

Concerns have been raised about the use of topical retinoids since the publication of isolated cases of characteristic retinoid embryopathy, originally described after oral use. A collaborative study of the European Network of Teratology Information Services was carried out to evaluate the rate of congenital malformations following first-trimester topical retinoid exposure. A population of 235 exposed pregnant women was compared with 444 controls. No significant differences were observed between groups with regard to the rates of spontaneous abortion (odds ratio [95% confidence interval], 1.5 [0.8-2.7]), minor birth defects (1.3 [0.4-3.7]), and major birth defects (1.8 [0.6-5.4]). No child showed features of retinoid embryopathy. The rate of elective termination in the exposed group was increased 3-fold (3.4 [1.5-7.8]). In conclusion, these results do not suggest an increased risk of retinoid embryopathy. However, according to current knowledge, topical retinoids cannot be advised for use during pregnancy because their risk/benefit ratio remains questionable.

Publication types

  • Multicenter Study

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Abortion, Spontaneous / epidemiology
  • Administration, Topical
  • Adolescent
  • Adult
  • Female
  • Humans
  • Middle Aged
  • Pregnancy
  • Pregnancy Outcome
  • Prospective Studies
  • Retinoids / administration & dosage*
  • Skin Diseases / drug therapy
  • Young Adult

Substances

  • Retinoids