Cetirizine, the active metabolite of hydroxyzine, is a non-sedating antihistamine used for the symptomatic relief of allergic conditions including rhinitis (hay fever) and chronic idiopathic urticaria.
Studies which have investigated maternal cetirizine use in pregnancy do not provide evidence of an increased risk of congenital malformation, intrauterine growth restriction or preterm delivery. Whilst the majority of controlled studies investigating spontaneous abortion risks following maternal cetirizine use in pregnancy provide no evidence of an association, a single study has described a possible increased risk which may necessitate further investigation. No studies have been located which investigated the risk of neurodevelopmental impairment following maternal use of cetirizine during pregnancy. Although reassuring, the available data is based upon a small number of studies detailing few exposed pregnancies.
Where use of a non-sedating antihistamine is required in pregnancy, and cetirizine is being considered, patients should be made aware of the limitations in the available data relating to the fetal safety of gestational cetirizine use. Exposure to cetirizine at any stage of pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.