The safety of oral fluconazole during the first trimester of pregnacy: a systematic review and meta-analysis.
BJOG. 2019 Aug 24;:
Authors: Zhang Z, Zhang X, Zhou YY, Jiang CM, Jiang HY
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 abstracted 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 (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 (>150 mg) users (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 < 0.001; n=2) in the offspring. In addition, exposure to fluconazole was significantly associated with an increased risk of spontaneous abortion (OR, 1.99; 95% CI, 1.38-2.88, P<0.001; n=3).
CONCLUSIONS: Oral fluconazole use during the first trimester of pregnancy appears to be associated with heart malformations and spontaneous abortion, but a causal link cannot be proven. This article is protected by copyright. All rights reserved.
PMID: 31446677 [PubMed - as supplied by publisher]