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

Reprod Toxicol. 2008 Sep;26(1):19-23. doi: 10.1016/j.reprotox.2008.05.053. Epub 2008 May 13.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abnormalities, Drug-Induced / diagnosis
  • Abnormalities, Drug-Induced / epidemiology*
  • Abnormalities, Drug-Induced / etiology
  • Abortion, Spontaneous / epidemiology*
  • Abortion, Spontaneous / etiology
  • Adolescent
  • Adult
  • Birth Weight
  • Cetirizine / adverse effects*
  • Female
  • Germany / epidemiology
  • Histamine H1 Antagonists, Non-Sedating / adverse effects*
  • Humans
  • Infant, Newborn
  • Maternal Exposure / adverse effects*
  • Maternal Exposure / statistics & numerical data
  • Middle Aged
  • Pregnancy
  • Pregnancy Trimester, First
  • Premature Birth / epidemiology*
  • Premature Birth / etiology
  • Prospective Studies

Substances

  • Histamine H1 Antagonists, Non-Sedating
  • Cetirizine