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Emtricitabine Pregnancy and Breastfeeding Warnings

Emtricitabine is also known as: Emtriva

Emtricitabine Pregnancy Warnings

Emtricitabine has been assigned to pregnancy category B by the FDA. The incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with emtricitabine in mice at exposures approximately 60-fold higher and in rabbits at approximately 120-fold higher than human exposures at the recommended daily dose. There are no controlled data in human pregnancy. Emtricitabine is only recommended for use during pregnancy when benefit outweighs risk.

To monitor fetal outcomes of pregnant women exposed to emtricitabine, an antiretroviral Pregnancy Registry as been established. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA).

Emtricitabine Breastfeeding Warnings

Samples of breast milk obtained from 5 HIV-1 infected women showed that emtricitabine is secreted in human milk. Breastfeeding infants whose mothers are being treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in such infants are unknown.

Emtricitabine is excreted into human milk. The effects in the nursing infant are unknown. The U.S. Public Health Service Centers for Disease Control and Prevention advise HIV-1 infected women not to breast-feed to avoid postnatal transmission of HIV-1 to a child who may not yet be infected. The manufacturer recommends that due to the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should not breastfeed while taking emtricitabine.

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