Desloratadine use during pregnancy and risk of adverse fetal outcomes: a nationwide cohort study
Abstract
BACKGROUND
Desloratadine is a frequently used drug for treatment of allergic disorders, which often also require treatment during pregnancy. However, information on the fetal safety of desloratadine use during pregnancy is limited.
OBJECTIVE
To investigate the association between desloratadine use during pregnancy and adverse fetal outcomes.
METHODS
From a cohort of 1,287,668 pregnancies identified in the Danish nationwide registries in the study period 2001-2016, users of desloratadine and loratadine during pregnancy were matched in a 1:1 ratio based on propensity scores to compare the risk of adverse fetal outcomes. We compared the risk of the primary outcomes major birth defects (among a total of 3348 pregnancies) and spontaneous abortion (5498 pregnancies) and the secondary outcomes preterm birth (5280 pregnancies), small size for gestational age (SGA) for birth weight (5436 pregnancies), and stillbirth (6776 pregnancies). Logistic regression was used to estimate prevalence odds ratio (OR) of major birth defects, preterm birth, and SGA, and Cox regression to estimate hazard ratio (HR) of spontaneous abortion and stillbirth. Sensitivity analyses included comparing with cetirizine use in pregnancy and with pregnancies unexposed to desloratadine but with prior use as additional comparator groups.
RESULTS
Use of desloratadine in pregnancy was not associated with a significant increased risk of major birth defects (prevalence OR, 1.07 95% confidence interval [CI], 0.77-1.50),…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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