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Terfenadine Pregnancy and Breastfeeding Warnings

Terfenadine is also known as: Seldane

Terfenadine Pregnancy Warnings

In a review of 229,101 deliveries to Michigan Medicaid patients, 1034 first-trimester exposures to terfenadine were recorded and 2042 exposures anytime during pregnancy. A total of 51 birth defects were reported with first-trimester exposure (44 expected) and included (observed/expected) 13/10 cardiovascular defects, 2 oral clefts, 12/2 polydactyly, and 3/1 limb reduction defects. A significant relative risk exists for polydactylies (5.4) and limb reduction defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)

Terfenadine has been assigned to pregnancy category C. Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Terfenadine should only be given during pregnancy when there are no alternatives and benefit outweighs the risk.

Terfenadine Breastfeeding Warnings

The carboxylic metabolite is detectable in limited amounts in human breast milk after terfenadine administration.

In a study of four lactating mothers, the highest concentration of the terfenadine metabolite in milk suggests that the maximum level of newborn exposure would not exceed 0.45% of the recommended maternal weight-corrected dose.

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