Any maternal exposure to oral fluconazole during pregnancy may increase the risk of spontaneous abortion and doses higher than 150 mg during the first trimester may increase the risk of cardiac septal closure anomalies, a new study suggests.
The study, published in the Canadian Medical Association Journal (CMAJ) this week, identified women exposed to low- (≤150 mg) and high-dose (>150 mg) fluconazole, and women who were not exposed. For each case of spontaneous abortion or stillbirth, up to five controls were randomly selected. For cases of major congenital malformation, all liveborn babies were considered controls.
Analysis revealed that the use of oral fluconazole during early pregnancy was associated with an increased risk of spontaneous abortion compared with no exposure (adjusted odds ratio [aOR] for low-dose treatment 2.23; 95% CI 1.96-2.54 and aOR for high-dose treatment 3.20; 95% CI 2.73-3.75).
Exposure to fluconazole during the first trimester did not increase the risk of overall major congenital malformations, however, exposure to high doses during the first trimester was associated with an increased risk of cardiac septal closure anomalies (aOR 1.81; 95% CI 1.04-3.14).
No association was found between exposure to fluconazole during pregnancy and the risk of stillbirth.