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Lamivudine Pregnancy and Breastfeeding Warnings

Lamivudine is also known as: Epivir, Epivir-HBV

Lamivudine Pregnancy Warnings

FDA pregnancy category: C Lamivudine should be used during pregnancy only if the benefit outweighs the risk to the fetus.

Animal studies have failed to reveal evidence of teratogenicity. While early embryolethality was observed in rabbit studies (exposure levels similar to human levels), this effect was not seen in high-dose studies in rats. Lamivudine was transferred to the fetus through the placenta in rat and rabbit studies. There are no controlled data in human pregnancy. A pregnancy registry has been established to monitor maternal-fetal outcomes of pregnant women exposed to lamivudine. Physicians are encouraged to register patients by calling 1-800-258-4263 (USA). FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Lamivudine Breastfeeding Warnings

In one study, lamivudine was measured in the milk of 20 HIV-infected women given 150 mg every 12 hours since week 38 of pregnancy. Mean lamivudine milk concentrations ranged from undetectable (less than 500 mcg/L) to 8200 mcg/L and was measured at any time relative to the dose. The breast milk-to-maternal serum ratio was approximately one to one.

HIV infection: Breastfeeding is not recommended during use of lamivudine. Hepatitis B infection: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and known benefits of breastfeeding. Excreted into human milk: Yes Excreted into animal milk: Yes The US Centers for Disease Control and Prevention and the American Academy of Pediatrics advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.

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