Stavudine Pregnancy and Breast Feeding Warnings
Stavudine is also known as: Zerit, Zerit XR
Overview
It is not known if Stavudine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Stavudine while you are pregnant. It is not known if Stavudine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Stavudine to the baby.
Stavudine Pregnancy Warnings
Stavudine has been assigned to pregnancy category C by the FDA. Stavudine has been shown to cross the placenta in the human ex vivo placenta model and in pregnant rats. Animal reproduction studies using drug exposure of 183 to 399 times the normal human exposure has revealed no evidence of teratogenicity. Early neonatal mortality in rats was increased using drug exposure of 399 times the normal human exposure. There are no controlled data in human pregnancy. Stavudine should only be used when the benefit outweighs the risk to the fetus.
To monitor maternal-fetal outcomes of pregnant women exposed to stavudine and other antiretroviral agents, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263. The Antiretroviral Pregnancy Registry reported prospective data from January 1989 to January 2004 involving 381 live births exposed to stavudine in combination with other antiretroviral agents during the first trimester and 131 live births exposed during the second or third trimester. 11 birth defects were reported from the first trimester exposure and 5 birth defects from the second or third trimester. The registry concluded that there was no pattern to the anomalies. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk.
Stavudine Lactation Warnings
There are no data on the excretion of stavudine into human milk. The drug is distributed into the milk in rats. HIV-infected mothers should not breast-feed their infants due to the risk of transmission of HIV via breast milk.
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