The safety of quinolones and fluoroquinolones in pregnancy: a meta-analysis.

BACKGROUND: Quinolones were contraindicated during pregnancy because of concerns regarding fetal malformations and carcinogenesis in animals. The literature is conflicting regarding their safety in humans. OBJECTIVES: To conduct a meta-analysis evaluating the risk for fetal malformations and pregnancy complications following exposure to quinolones during pregnancy. SEARCH STRATEGY: We searched Embase, PubMed, Medline, the Cochrane database, clinicaltrials.gov, and Dart Databases. We added articles found through the references of included articles. SELECTION CRITERIA: Relevant English citations using the terms quinolone/s, fluoroquinolone/s, and pregnancy in humans. Exclusion criteria were case reports, reviews, and articles without data regarding the study outcomes. DATA COLLECTION AND ANALYSIS: Two authors performed the database search, assessment of eligibility, and abstraction of data from included studies. Disagreement was settled by consensus among all authors. The pooled odds ratios (with 95% CIs) were estimated. The Cochrane's Q-test of heterogeneity and I² were used for the measurement of heterogeneity. A total of 256 papers were retrieved, 13 of which met the inclusion criteria and were then analysed. MAIN RESULTS: No association was found between quinolones and fetal malformations (pooled odds ratio, OR 1.08; 95% CI 0.96-1.21), preterm delivery (pooled OR 0.97; 95% CI 0.75-1.24), stillbirth (pooled OR 1.11; 95% CI 0.34-3.6), or miscarriage (pooled OR 1.78; 95% CI 0.93-3.38). CONCLUSIONS: Quinolones are not associated with unfavourable pregnancy outcomes; however, larger studies are needed before safety is established. Until then, it is suggested that quinolones should not be used as a first-line therapy during the first trimester. TWEETABLE ABSTRACT: Quinolones were associated with favourable pregnancy outcomes; caution should be taken in the first trimester.