Are Vaginal Antimycotics Associated with an Increased Risk for Miscarriage?
BACKGROUND AND PURPOSE:
Vulvovaginal candidiasis (VVC) may occur in more than 20% of pregnant women
A previous study suggested an increased risk of miscarriage after the use of vaginal-antimycotic agents for vulvovaginal candidiasis
Daniel et al. (AJOG, 2018) examined whether risk for spontaneous abortions is increased following first-trimester exposure to vaginal antimycotics
Population-based retrospective cohort study
Participants: All clinically apparent pregnancies admitted for birth or spontaneous abortion
A computerized database of medication dispensation was linked with computerized databases containing information on births and spontaneous abortion
Time-varying Cox regression models, adjusted for confounding variables such as mother’s age, hypothyroidism, diabetes mellitus, hypercoagulable or inflammatory conditions, recurrent miscarriage, IUD, ethnicity, tobacco use and the year of admission were used to assess the association
65,457 pregnancies were included in the study
58,949 (90.1%) ended with birth
6,508 (9.9%) ended with spontaneous abortion
Overall, 5% of pregnancies were exposed to vaginal antimycotic medications until the 20th gestational week
4.2% were exposed to clotrimazol
1% were exposed to miconazole
Exposure to vaginal antimycotics was not associated with spontaneous abortions as a group
Crude hazard ratio (HR) 1.11; 95% CI, 0.96–1.29
adjusted HR 1.11; 95% CI, 0.96–1.29
Clotrimazole was not associated with increased risk
adjusted HR 1.05; 95% CI, 0.89–1.25
Miconazole was also not associated with increased risk
adjusted HR 1.34; 95% CI, 0.99–1.80
Dosage did not impact the findings
This study found no evidence that taking antimycotics (clotrimazole and miconazole) during the first trimester is associated with increased risk for miscarriage
Following a Danish study in 2016 by Nielsen et al. (JAMA, 2016), which concluded that fluconazole was associated with miscarriage, the FDA undertook a review to determine the safety of fluconazole in pregnancy. The FDA concluded (October 2019) that
Based on our reviews of several studies, FDA has determined that the available data do not provide conclusive evidence of an increased risk of miscarriage or stillbirth with a single 150 mg dose of oral fluconazole (Diflucan)
We reviewed the 2016 study cited in this DSC and four additional epidemiological studies
We approved updated prescribing information in 2018 to include all available information on the use of fluconazole in women who are pregnant or breastfeeding
It adequately addresses the potential risk of harm to unborn babies
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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