Terconazole topical Pregnancy and Breastfeeding Warnings
Terconazole topical Pregnancy Warnings
In a review of 229,101 deliveries to Michigan Medicaid patients, 1167 first-trimester exposures to terconazole and 7551 exposures any time during pregnancy were recorded. A total of 34 birth defects were reported with first trimester exposure (48 expected) and included (observed/expected) 14/12 cardiovascular defects, 3/2 polydactyly, 1 limb reduction, and 1 hypospadias. These data do not support an association between terconazole use and birth defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)
Terconazole topical has been assigned to pregnancy category C by the FDA. Animal studies utilizing high oral and subcutaneous doses have not revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Since it is absorbed from the human vagina, terconazole topical should not be used during the first trimester of pregnancy unless the benefit to the mother outweighs the risk to the fetus. Terconazole topical is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Terconazole topical Breastfeeding Warnings
There are no data on the excretion of terconazole topical into human milk. At least one manufacturer recommends that caution be used when administering terconazole topical to nursing women. Other manufacturers recommend 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.
References for breastfeeding information
- "Product Information. Terazol 3 (terconazole)." Ortho Pharmaceutical Corporation, Raritan, NJ.
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