The safety of oral fluconazole during the first trimester of pregnancy: a systematic review and meta‐analysis

Background Oral fluconazole is used to treat vulvovaginal candidiasis during pregnancy. However, there are concerns regarding the pregnancy outcomes following exposure to fluconazole. Objectives To evaluate the pregnancy outcomes associated with exposure to oral fluconazole during the first trimeste...

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Bibliographic Details
Published in:BJOG : an international journal of obstetrics and gynaecology 2019-12, Vol.126 (13), p.1546-1552
Main Authors: Zhang, Z, Zhang, X, Zhou, Y‐y, Jiang, C‐m, Jiang, H‐y
Format: Article
Language:English
Subjects:
Abnormalities, Drug-Induced
Administration, Oral
Antifungal
Antifungal agents
Antifungal Agents - administration & dosage
Antifungal Agents - adverse effects
Candidiasis
Candidiasis, Vulvovaginal - drug therapy
Congenital defects
Craniofacial Abnormalities - chemically induced
Evidence-based medicine
Female
Fluconazole
Fluconazole - administration & dosage
Fluconazole - adverse effects
Health risk assessment
Humans
maternal
Meta-analysis
Miscarriage
neonatal
Newborn babies
Patient Safety
Pregnancy
Pregnancy Trimester, First
prenatal
Systematic review
Tetralogy of Fallot
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Summary:Background Oral fluconazole is used to treat vulvovaginal candidiasis during pregnancy. However, there are concerns regarding the pregnancy outcomes following exposure to fluconazole. Objectives To evaluate the pregnancy outcomes associated with exposure to oral fluconazole during the first trimester of pregnancy. Search strategy A systematic literature search was conducted to identify relevant studies published from inception until April 2019. Selection criteria Relevant English‐language citations using the terms oral fluconazole and pregnancy in humans. Data collection Two reviewers independently ed data and assessed study quality. Main results Oral fluconazole use during the first trimester of pregnancy was marginally associated with an increased risk of congenital malformations (odds ratio [OR] 1.09, 95% CI 0.99–1.2, P = 0.088; n = 6 studies), whereas in the subgroup analysis, this association existed only for high‐dose users (>150 mg) (OR 1. 19, 95% CI 1.01–1.4, P = 0.039; n = 2). Exposure to fluconazole also increased the risk of heart malformations (OR 1.31, 95% CI 1.09–1.57, P = 0.003; n = 4), cardiac septal defects (OR 1.3, 95% CI 1.1–1.67, P = 0.047; n = 3), and tetralogy of Fallot (OR 3.39 95% CI 1.71–6.74, P 
ISSN:1470-0328
1471-0528
DOI:10.1111/1471-0528.15913