Aviva Ziv1, Reem Masarwa1, Amichai Perlman1, Danny Ziv1, Ilan Matok2. 1. Pharmacoepidemiology Research Unit, Division of Clinical Pharmacy Institute for Drug Research, School of Pharmacy, The Hebrew University of Jerusalem, Jerusalem, Israel. 2. Pharmacoepidemiology Research Unit, Division of Clinical Pharmacy Institute for Drug Research, School of Pharmacy, The Hebrew University of Jerusalem, Jerusalem, Israel. Ilan.Matok@ekmd.huji.ac.il.
Abstract
PURPOSE: Quinolones, and the fluoroquinolones subgroup, are a class of antibiotics commonly used for the treatment of a wide variety of infections. However, their safety profile in pregnant women is controversial. The association between fluoroquinolones and arthropathy was primarily described in immature animals, and only rarely in humans, yet it has led to the restricted use of quinolones during pregnancy. We aimed to assess their safety during pregnancy. METHODS: A systematic review and meta-analysis assessing the safety of quinolone exposure during any time of pregnancy, and during first trimester alone, was performed. The systematic review was performed using MEDLINE and EMBASE, and followed the PRISMA guidelines. Pooled effect sizes with corresponding 95% confidence intervals (CI) were calculated using random effects models, comparing fetal outcomes of quinolone exposed and non-exposed pregnancies. Only cohort and case control studies were included in the meta-analysis. RESULT: Twelve studies met the inclusion criteria. Exposure to quinolones during first trimester was not associated with an increased risk for birth defects (pooled odds ratio (OR) = 0.89, 95% CI 0.72-1.09, I2 = 0%), stillbirth (OR = 1.32, 95% CI 0.33-5.34, I2 = 16%), preterm birth (OR = 1.10, 95% CI 0.83-1.48, I2 = 41%) and low birth weight (OR = 1.29, 95% CI 0.54-3.12, I2 = 67%). CONCLUSION: The use of quinolones during the first-trimester of pregnancy was not associated with an increased risk of birth defects, stillbirths, preterm births or low birth weight. STUDY REGISTRY: PROSPERO CRD42017060573.
PURPOSE:Quinolones, and the fluoroquinolones subgroup, are a class of antibiotics commonly used for the treatment of a wide variety of infections. However, their safety profile in pregnant women is controversial. The association between fluoroquinolones and arthropathy was primarily described in immature animals, and only rarely in humans, yet it has led to the restricted use of quinolones during pregnancy. We aimed to assess their safety during pregnancy. METHODS: A systematic review and meta-analysis assessing the safety of quinolone exposure during any time of pregnancy, and during first trimester alone, was performed. The systematic review was performed using MEDLINE and EMBASE, and followed the PRISMA guidelines. Pooled effect sizes with corresponding 95% confidence intervals (CI) were calculated using random effects models, comparing fetal outcomes of quinolone exposed and non-exposed pregnancies. Only cohort and case control studies were included in the meta-analysis. RESULT: Twelve studies met the inclusion criteria. Exposure to quinolones during first trimester was not associated with an increased risk for birth defects (pooled odds ratio (OR) = 0.89, 95% CI 0.72-1.09, I2 = 0%), stillbirth (OR = 1.32, 95% CI 0.33-5.34, I2 = 16%), preterm birth (OR = 1.10, 95% CI 0.83-1.48, I2 = 41%) and low birth weight (OR = 1.29, 95% CI 0.54-3.12, I2 = 67%). CONCLUSION: The use of quinolones during the first-trimester of pregnancy was not associated with an increased risk of birth defects, stillbirths, preterm births or low birth weight. STUDY REGISTRY: PROSPERO CRD42017060573.
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