RT Journal Article
T1 Prenatal Exposure to Macrolides and Risk of Congenital Malformations: A Meta-Analysis
A1 Mallah, Narmeen
A1 Tohidinik, Hamid Reza
A1 Etminan, Mahayr
A1 Figueiras Guzmán, Adolfo
A1 Takkouche, Bahi
K1 Macrolides
K1 Congenital malformations
K1 Meta-analysis
K1 Fetal safety
AB Introduction: Macrolides are widely used during pregnancy; however, their fetal safety remains uncertain. We performed a meta-analysis to assess the relation between prenatal exposure to macrolides and occurrence of congenital malformations.    Methods: We searched MEDLINE, EMBASE and other databases until June 12th, 2019. We assessed the quality of the studies and checked for heterogeneity and publication bias. We performed 3 different analyses and compared the effect of macrolides to each of the following unexposed populations: Group 1: babies unexposed to any medicine before birth, Group 2: babies exposed to non-macrolides antibiotics/non-teratogens, and Group 3: mixed population of the first and second comparators.  Results: A weak association between macrolides and congenital malformation of any type was observed when macrolides were compared to the mixed population [ORgroup 3: 1.06 (95%CI 1.01, 1.10)]. Subgroup analysis showed that this weak association is restricted to fetus exposure in the first trimester of pregnancy [OR: 1.06 (95%CI: 1.01, 1.11)] and to cohort studies [OR: 1.07 (95%CI: 1.02, 1.13). Digestive system malformations were found to be slightly associated with prenatal exposure to macrolides [ORgroup 3: 1.14 (95%CI: 1.02, 1.26)]. Musculoskeletal system was also found to be potentially affected [ORgroup 2: 1.21 (95%CI: 1.08, 1.35) and ORgroup 3: 1.15 (95%CI: 1.05, 1.26)]. European studies showed a slightly stronger association than American studies in these two comparisons.  Conclusions: Our study suggests a weak association of macrolides’ prenatal use and congenital malformations, limited to exposure in early pregnancy, and musculoskeletal and digestive systems. In addition to studies with a larger control of confounding, risk-benefit research is needed to determine the usefulness of macrolides during pregnancy.
PB Springer
YR 2020
FD 2020-03-01
LK http://hdl.handle.net/10347/32825
UL http://hdl.handle.net/10347/32825
LA eng
NO Mallah, N., Tohidinik, H.R., Etminan, M. et al. Prenatal Exposure to Macrolides and Risk of Congenital Malformations: A Meta-Analysis. Drug Saf 43, 211–221 (2020).
NO This version of the article has been accepted for publication, after peer review (when applicable) and is subject to Springer Nature’s AM terms of use, but is not the Version of Record and does not reflect post-acceptance improvements, or any corrections. The Version of Record is available online at: http://dx.doi.org/10.1007/s40264-019-00884-5
DS Minerva
RD 24 abr 2026