Using oral fluconazole during pregnancy was not tied to a higher risk of stillbirth, according to a study published in JAMA.
Oral antifungal use during pregnancy is generally not recommended but data has shown 0.5 to 4% of pregnant women still receive this treatment. Researchers from the Karolinska Institute previously found that fluconazole use during pregnancy was tied to an increased risk of spontaneous abortion and possible stillbirth.
“There are concerns based on animal data that oral fluconazole use in pregnancy may lead to fetal death. Given this concern and the paucity of studies in humans, we wanted to investigate the issue further,” explained lead author Björn Pasternak, MD, PhD, associate professor at Karolinska Institute’s Department of Medicine in Solna.
For this study, Pasternak and colleagues aimed to identify whether any fluconazole use during pregnancy was associated with stillbirth (fetal loss after 22 completed weeks) and neonatal death (0 to 27 days after live birth). A total of 10,669 women from the national Swedish and Norwegian register database were compared to 106,387 women who did not use fluconazole; baseline characteristics were similar between both groups.
Among fluconazole-exposed pregnancies, there were 2.7 stillbirths per 1000 compared with 3.6 stillbirths per 1000 among unexposed pregnancies (hazard ratio [HR] 0.76, 95% CI, 0.52-1.10). There were 1.2 neonatal deaths per 1000 exposed pregnancies and 1.7 neonatal deaths per 1000 unexposed pregnancies (risk ratio [RR] 0.73, 95% CI, 0.42-1.29).
The data were similar for fluconazole doses that were ≤300mg or >300mg. Additional analyses according to other covariates showed consistent results with the primary analyses.
Based on the findings, it was concluded that fluconazole use during pregnancy was not associated with significantly increased risks of stillbirth or neonatal death. However, the authors cautioned that the confidence intervals were wide and neither result was statistically significant.
“Although the data on fluconazole use in pregnancy suggest no increased risk of stillbirth, additional studies should be conducted and the collective body of data scrutinized by drug authorities before recommendation to guide clinical decision making are made, and weighed against the benefits of therapy,” Dr. Pasternak concluded
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