Stavudine Pregnancy and Breastfeeding Warnings
Stavudine is also known as: Zerit, Zerit XR
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 studies have failed to reveal evidence of teratogenicity using drug exposures of 183 and 399 times the normal human exposure in rabbits and rats, respectively. The fetal incidence of a common skeletal variation, unossified or incomplete ossification of sternebra, and early neonatal mortality were increased in rats using drug exposure of 399 times the normal human exposure. There are no controlled data in human pregnancy. Stavudine is only recommended for use during pregnancy when benefit outweighs risk.
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 Breastfeeding Warnings
There are no data on the excretion of stavudine into human milk; however, it is excreted into rat milk. 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. 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 breast-feed while taking stavudine.
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