Is zyrtec safe during first trimester of pregnancy

Many people with allergies take antihistamines for relief. Studies show that several over-the-counter allergy medications are safe to use during pregnancy, including

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  • chlorpheniramine

  • dexchlorpheniramine

  • hydroxyzine

Newer antihistamines, such as cetirizine and loratadine, also may be safe. There also is a corticosteroid nasal spray that is safe to use during pregnancy. But one of the most common decongestants, pseudoephedrine, has been linked to a small risk of abdominal wall birth defects. Do not use pseudoephedrine during the first 3 months of pregnancy.

A prospective observational cohort study

Author links open overlay panelCorinnaWeber-SchoendorferPersonEnvelopeChristofSchaefer

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https://doi.org/10.1016/j.reprotox.2008.05.053Get rights and content

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.

Introduction

Cetirizine is a non-sedating long-acting antihistamine with some mast-cell stabilizing activity. It is a metabolite of hydroxyzine. Cetirizine is used for the symptomatic relief of allergic conditions, such as rhinitis and urticaria [1]. Allergies are common in young and also pregnant women, but human pregnancy experience is so far limited.

No animal teratogenicity is described. According to the manufacturer administration up to 40, 180, and 216 times the human dose in pregnant mice, rats, and rabbits, respectively, did not produce an increase in congenital malformations in the offspring. In one published study, which we have examined only in abstract, there was no teratogenicity in rats or animals even at maternal toxic doses of 500 times the maximum human dose of cetirizine [2].

In 1997 Einarson et al. [3] published the first prospective cohort study on cetirizine and hydroxyzine in pregnancy. Among 39 cetirizine-exposed, 53 hydroxyzine-exposed pregnancies and a control group no significant differences were found in the pregnancy outcome concerning the rate of major or minor birth defects, fetal losses, mean birth weight, and gestational age at delivery. That was confirmed by the case series of Paulus et al. [4] who had collected 144 cetirizine-exposed pregnancies. Källén [5] published a study using the prospectively collected data of the Swedish Medical Birth Registry. He compared groups of antihistamines taken in early pregnancy concerning delivery outcome with all deliveries in the population. The two main antihistamine groups were drugs preferentially used for nausea and vomiting and drugs used for allergy. Cetirizine-exposed women (n = 917) were included in the allergy group. The percentage of infants with malformations was 3.16% in the general population and 3.95% after cetirizine, a difference which was statistically not significant.

With the evaluation of our data we wanted to assess the safety of cetirizine during the first trimester of pregnancy.

Section snippets

Materials and methods

Our prospective study enrolled women who or whose physician contacted our teratology information service (TIS) in regard to 1st trimester exposure to cetirizine between 1992 and 2006. A structured questionnaire for details of exposure was used at the first contact during (early) pregnancy and the following information was recorded before the pregnancy outcome was known: details of drug exposure (timing in pregnancy, dose, and duration), maternal demographics, medical and obstetric history.

Results

A total of 196 pregnant women with first trimester exposure (≤12 weeks after LMP) to cetirizine were enrolled in this study. The treatment indications (n = 195) were allergies in general (n = 105; 53.8%), allergic rhinitis (n = 46; 23.6%), urticaria (n = 23; 11.8%), asthma (n = 9; 4.6%) and others (n = 12; 6.2%). Among the latter there were two mothers who took an overdosage of cetirizine. One took 80 mg in week 7, the other 100 mg in week 10. The course of both pregnancies was uneventful and resulted in

Comment

Our observational study covering 196 pregnant women who had taken cetirizine during organogenesis found no drug specific adverse pregnancy outcome compared to a control group of 1686 pregnant women. This is in accordance with the results of previous studies.

In contrast to retrospective documentation of exposure data or filled prescriptions, a major advantage of our prospective observational data is their reliability with respect to the exposure time as the need for consultation arises from the

Conflict of interest

None.

Acknowledgement

The study was financed by the German Bundesinstitut für Arzneimittel und Medizinprodukte (BfArm).

References (9)

  • A. Einarson et al.

    Prospective controlled study of hydroxyzine and cetirizine in pregnancy

    Ann Allergy Asthma Immunol

    (1997)

  • M. Kamijima et al.

    Reproductive and developmental toxicity studies of cetirizine in rats and rabbits

    Clin Rep

    (1994)

  • W. Paulus et al.

    Pregnancy outcome after exposure to cetirizine/levocetirizine in the first trimester—a prospective controlled study

    Reprod Toxicol

    (2004)

There are more references available in the full text version of this article.

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    Some oral antihistamines like Allegra (fexofenadine), Benadryl (diphenhydramine), Chlor-Trimeton (chlorpheniramine), Claritin (loratadine) and Zyrtec (cetirizine) appear to be safe after the first trimester. That means they have caused no known harm in studies so far.

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    Many allergy drugs may be fine to keep taking during pregnancy, but have the discussion so you can have peace of mind. Oral antihistamines, like cetirizine (Zyrtec), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), fexofenadine (Allegra), and loratadine (Claritin) seem to be safe.

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    Can I take Zyrtec 5 weeks pregnant?

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