Azatadine Pregnancy and Breastfeeding Warnings

Brand names: Optimine

Azatadine Pregnancy Warnings

Azatadine has been assigned to pregnancy category B by the FDA. Animal studies at higher than recommended doses have revealed no evidence of fetal harm. There are no controlled data in human pregnancy. Azatadine is only recommended for use during pregnancy when benefit outweighs risk.

In a review of 229,101 deliveries to Michigan Medicaid patients, 127 first-trimester exposures to azatadine and 1311 exposures anytime during pregnancy were recorded. A total of six birth defects were reported with first trimester exposure (5 expected) and included one oral clefts and one limb reduction. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association between azatadine and birth defects.

A review of prenatal drug use in 3026 women with premature infants demonstrated an increased risk of retrolental fibroplasia with antihistamine use during the last two weeks of pregnancy. The dosage used or the particular antihistamine was not specified. The incidence of retrolental fibroplasia in premature infants exposed in utero to antihistamine during this time was 21% compared to 11% in premature infants not exposed.

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