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.