The safety of cetirizine during pregnancy. A prospective observational cohort study

Objective: To assess the safety of cetirizine during pregnancy. Study design: A prospective observational cohort study with data of the Berlin teratology information center from 1992 until 2006. Pregnancy outcome was compared between a cohort of pregnant women exposed to cetirizine during the first trimester (n = 196) and a control group not exposed to potential teratogens (n = 1686). Results: Major birth defects were not more common in the study group than in the control group (OR 1.07; CI 0.21-3.59). We also compared the crude rate of spontaneous abortions (OR 0.97: CI 0.54-1.65). of preterm deliveries (OR 0.76; CI 0.35-1.5), and the birth weight of term newborns (p = 0.13). Conclusions: This prospective observational study on cetirizine in pregnancy suggests that the use of cetirizine is relatively safe during the first trimester. (C) 2008 Elsevier Inc. All rights reserved.