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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