The safety of cetirizine during pregnancy. A prospective observational cohort study.
OBJECTIVE
To assess the safety of cetirizine during pregnancy.


METHODS
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.
Pharmakovigilanz- und Beratungszentrum Embryonaltoxikologie Berlin, Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Spandauer Damm 130, Haus 10, 14050 Berlin, Germany. weber@embryotox.de
Corinna
C
Weber-Schoendorfer
Christof
C
Schaefer
D000014:Abnormalities, Drug-Induced / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology; D000022:Abortion, Spontaneous / Q000453:epidemiology* / Q000209:etiology; D000293:Adolescent; D000328:Adult; D001724:Birth Weight; D017332:Cetirizine / Q000009:adverse effects*; D005260:Female; D005858:Germany / Q000453:epidemiology; D039563:Histamine H1 Antagonists, Non-Sedating / Q000009:adverse effects*; D006801:Humans; D007231:Infant, Newborn; D018811:Maternal Exposure / Q000009:adverse effects* / Q000706:statistics & numerical data; D008875:Middle Aged; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D047928:Premature Birth / Q000453:epidemiology* / Q000209:etiology; D011446:Prospective Studies
D039563:Histamine H1 Antagonists, Non-Sedating; D017332:Cetirizine