The fetal safety of cetirizine: An observational cohort study and meta-analysis

Abstract

Cetirizine, a second-generation antihistamine, is an active metabolite of hydroxyzine used in the treatment of allergies, but the data on fetal safety are inconclusive. Pregnant women who were counselled by the 'Motherisk Program' regarding cetirizine exposure were enrolled in a cohort study and compared with pregnant women counselled for non-teratogenic exposures. The objective was to measure the rate of adverse pregnancy outcomes. Subsequently, we also conducted a meta-analysis of cohort studies that examined the pregnancy outcomes of women exposed to hydroxyzine or cetirizine during pregnancy. In the cohort study, there were no significant differences in the rates of major malformations between the cetirizine exposed and comparison group. In the meta-analysis, cetirizine was not associated with increased teratogenic risk. In contrast, a meta-analysis of cetirizine and hydroxyzine studies showed a marginal association with major malformations. Cetirizine is not associated with a clinically important increase in risk of adverse fetal outcomes.

Management of ocular allergy

“…The use of systemic medications should be minimized if possible. Pregnant (especially in the first trimester) and lactating women can receive second‐generation oral antihistamine treatment (no teratogenic effects have been described), and low concentrations of these drugs are secreted in breast milk …”

Rhinitis 2020: A practice parameter update

“…Cetirizine was not associated with increase rate of major malformations or increase teratogenic risk. 585 A study using the UCB Pharma Patient Safety Database up to February 2015 reaffirmed the safety of cetirizine in pregnancy. 586 A 2013 study using data from a multicenter case-control surveillance program of birth defects in North America did not support previously posited associations between antihistamines, notably diphenhydramine, loratadine, and chlorpheniramine, and major congenital anomalies.…”

Safety of cetirizine in pregnancy

“…Similarly, data from the Swedish Medical Birth Registry, which included 917 women who had taken CTZ during their pregnancy, showed no association with malformations or adverse delivery outcomes, compared to the general population (K€ all en 2002). A cohort study involving 78 pregnant women exposed to CTZ in the first, and 56 in the second or third trimester demonstrated no increased risk of major malformations or spontaneous abortions when CTZ was taken during organogenesis, compared to the control group of women taking non-teratogenic agents (Etwel et al 2014). Similarly, a meta-analysis of 10 studies involving 1293 pregnant women reported no 8 (100.0) 0 0 0 0 Third (n ¼ 2) 2 (100.0) 0 0 0 0 Unknown (n ¼ 5) 5 (100.0) 0 0 0 0 Trimesters exposed n (%) 1 only (n ¼ 8) 4 (50.0) 3 (37.5) 1 (12.5) 0 0 2 only (n ¼ 3)…”

“…Prospective reports (n ¼ 41) n (%) increased risk of major malformations or other adverse foetal outcomes following hydroxyzine or CTZ exposure, compared to the unexposed controls (Etwel et al 2014). The limitations of the analysis include that the UCB Pharma Patient Safety Database is a surveillance reporting tool for adverse events, rather than an analysis tool, and the data collection process is tailored to pharmacovigilance purposes.…”

“…Cetirizine, an active metabolite of hydroxyzine, is a second-generation antihistamine used for the symptomatic relief of allergic conditions, such as AR and urticaria (Zhang et al 2013). Studies have demonstrated that exposure to CTZ during pregnancy does not appear to be associated with an increased safety risk for mothers and infants (Einarson et al 1997;Weber-Schoendorfer and Schaefer 2008;Etwel et al 2014). The American College of Obstetricians and Gynecologists and the American College of Allergy, Asthma and Immunology (ACOG-ACAAI) recommend CTZ for pregnant women who would benefit from antihistamine treatment (Blaiss 2003).…”