Exposure to fluconazole and risk of congenital malformations in the offspring: A systematic review and meta-analysis.
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.
The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children and University of Toronto, 555 University Ave, Toronto, ON M5G 1X8, Canada; Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College street, Toronto, ON M5S 3M2, Canada; Department of Pharmacology & Toxicology, College of Pharmacy, King Saud University, Riyadh, KSA.
Abdulaziz M S
AM
Alsaad
The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children and University of Toronto, 555 University Ave, Toronto, ON M5G 1X8, Canada; Terafar-Izmir Katip Celebi University Teratology Information, Training and Research Center, Izmir, Turkey.
Yusuf C
YC
Kaplan
The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children and University of Toronto, 555 University Ave, Toronto, ON M5G 1X8, Canada; Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College street, Toronto, ON M5S 3M2, Canada. Electronic address: gkoren@sickkids.ca.
Gideon
G
Koren
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology* / Q000209:etiology; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy*; D019465:Craniofacial Abnormalities / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D015725:Fluconazole / Q000009:adverse effects*; D006330:Heart Defects, Congenital / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D016239:MEDLINE; D011247:Pregnancy; D011261:Pregnancy Trimester, First
D000935:Antifungal Agents; D015725:Fluconazole
Cardiovascular defects; Fluconazole; Infants; Pregnancy; Teratogenicity; Vulvovaginal candidiasis