Lamivudine Pregnancy and Breastfeeding Warnings
Lamivudine is also known as: Epivir, Epivir-HBV
Lamivudine Pregnancy Warnings
Lamivudine has been assigned to pregnancy category C by the FDA. High-dose studies in rats have failed to reveal evidence of fetotoxicity. However, there is some indication of early embryolethality in rabbit studies using doses proportional to normal human dosages. There are no controlled data in human pregnancy. Lamivudine should only be given during pregnancy when benefit outweighs risks.
An Antiretroviral Pregnancy Registry has been established to monitor maternal-fetal outcome of lamivudine exposures during pregnancy. To register patients, physicians should call 800-258-4263.
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.
Lamivudine is excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, mothers should not breast-feed while taking lamivudine. The U.S. Public Health Service Centers for Disease Control and Prevention advise HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child who may not yet be infected.
See Also...
- Lamivudine use while Breastfeeding (in more detail)
- lamivudine Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
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