Hydroxyzine Pregnancy and Breastfeeding Warnings
Hydroxyzine Pregnancy Warnings
Hydroxyzine has not been formally assigned to pregnancy category by the FDA. Hydroxyzine has been assigned to pregnancy Risk Factor C by Briggs et al. Animal studies have revealed evidence of teratogenicity when given in high doses. There are no controlled data in human pregnancy. The manufacturer considers hydroxyzine to be contraindicated in early pregnancy due to lack of clinical data. Hydroxyzine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 50 were exposed to hydroxyzine during the first trimester. Five malformed children were reported suggesting a possible relationship between first trimester use and congenital defects. Data from the Michigan Medicaid Birth Defects Study revealed an association between the use of hydroxyzine and birth defects during the first trimester (personal communication. F. Rosa, MD, FDA, 1993). This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 828 newborns were exposed to hydroxyzine during the first trimester. A total of 48 birth defects were observed (42 expected). The defects included cardiovascular, spina bifida, polydactyly, limb reduction defects, hypospadias, and oral clefts. Only with the latter is there a suggestion of a possible association, however, other factors such as the mother's disease, concurrent drug use, and chance, may be involved.
Hydroxyzine Breastfeeding Warnings
There are no data on the excretion of hydroxyzine into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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