Pregnancy and breastfeeding
Stavudine has been demonstrated to affect the fetus in animal studies but no data are available from human studies. Pregnant women should therefore be given stavudine only if the potential benefits outweigh the potential harm to the fetus. Additionally, there have been case reports of fatal lactic acidosis in pregnant women receiving combination therapy of stavudine and didanosine with other antiviral agents.The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants, in order to avoid the risk of HIV transmission through breast milk. There is also evidence that stavudine gets into animal breast milk, although no data are available for human breast milk. Children
Stavudine is safe for use in children infected with HIV from birth through adolescence. Adverse effects and safety profile are the same as adults. Elderly
There is no data available for stavudine use in HIV-infected adults aged 65 years or older. However, among 12,000 people over the age of 65, 30% developed peripheral neuropathy. Additionally, since the elderly are more likely to have decreased renal function, they are more likely to develop toxic side effects. Adverse events
Common side effects
Nausea
Vomiting
Diarrhea
Headache
Upset stomachSevere side effects
Peripheral neuropathy
Lactic acidosis
Pancreatitis
Hepatotoxicity
Hepatomegaly with steatosis
Lipoatrophy/lipodystrophy (fat redistribution/accumulation)Individuals are monitored for the development of these serious adverse effects. The development of peripheral neuropathy is shown to be dose related, and may be resolved if the drug is discontinued.
The pharmaceutical company Bristol-Myers Squibb manufactures the drug under the trade name Zerit.It is also the first drug to be granted parallel track status in 1992, by the US Food and Drug Administration (FDA), which allowed for the agency to make Stavudine available to patients before being approved. Stavudine was submitted under the FDAs accelerated approval process. Through this process, Stavudines effectiveness was measured by its effect on the surrogate marker, CD4, instead of clinical endpoints. The FDA concluded that an increase in CD4 cell counts was an indicator of how effective the drug would be against AIDS and HIV infection. Stavudine was the fourth drug to be approved for the treatment of AIDS and HIV infection by the FDA on June 27, 1994. Even after approval, studies were continued to evaluate the clinical benefit of the drug. If there is no indication of clinical benefits, the accelerated approval may be withdrawn.In 2018, Mylan Pharmaceuticals discontinued manufacturing stavudine 20 mg, 30 mg, and 40 mg capsules. References
External links
"Stavudine". Drug Information Portal. U.S. National Library of Medicine.