Exposure to fluconazole and risk of congenital malformations in the offspring: A systematic review and meta-analysis

Reprod Toxicol. 2015 Apr:52:78-82. doi: 10.1016/j.reprotox.2015.02.009. Epub 2015 Feb 25.

Abstract

Vulvovaginal candidiasis (VVC) affects up to 75% of women at least once during their lifetime, mostly during the reproductive age, and recurrence rate is about 50%. Because half of all pregnancies are unplanned and pregnant women have an increased risk of VVC recurrence, the likelihood of inadvertently being exposed to fluconazole in pregnancy is increased. Thus, we aimed to examine the risk of congenital malformations in the offspring of women exposed to fluconazole in the first trimester of pregnancy. The rate for overall malformations was 1.10 (95% CI 0.98-1.25), for heart defect was 1.29 (95% CI 1.05-1.58), for craniofacial defects was 1.25 (95% CI 0.88-1.77), and for limb/musculoskeletal defects was 0.82 (95% CI 0.59-1.13). In conclusion, the use of fluconazole in the first trimester does not appear to increase the overall risk for congennital malformations. More studies are needed to address the potential increased rate of heart defects.

Keywords: Cardiovascular defects; Fluconazole; Infants; Pregnancy; Teratogenicity; Vulvovaginal candidiasis.

Publication types

  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Review
  • Systematic Review

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology*
  • Abnormalities, Drug-Induced / etiology
  • Antifungal Agents / adverse effects*
  • Antifungal Agents / therapeutic use
  • Candidiasis, Vulvovaginal / drug therapy*
  • Craniofacial Abnormalities / chemically induced
  • Craniofacial Abnormalities / epidemiology
  • Female
  • Fluconazole / adverse effects*
  • Heart Defects, Congenital / chemically induced
  • Heart Defects, Congenital / epidemiology
  • Humans
  • MEDLINE
  • Pregnancy
  • Pregnancy Trimester, First

Substances

  • Antifungal Agents
  • Fluconazole