Zerit and Pregnancy

The FDA has classified Zerit as a pregnancy Category C medication, meaning it may not be safe for use during pregnancy. Although Zerit has not been adequately studied in pregnant women, the medication has been shown to cause miscarriages and birth defects when given in high doses to pregnant rats and rabbits. Therefore, be sure to talk to your healthcare provider about the risks and benefits of Zerit and pregnancy before taking the medication.

 

Zerit and Pregnancy: An Overview

Zerit® (stavudine) is a prescription AIDS and HIV medication. Because it has not been adequately studied in pregnant women, it is not known if Zerit is safe for use during pregnancy. However, in some circumstances, the benefits of Zerit may outweigh the potential risks.
 

Zerit and Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans, but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating. While there have been no adequate studies done on Zerit in pregnant women, Zerit has been studied in pregnant animals.
 
Zerit has been studied in pregnant rats and rabbits. When a very high Zerit dosage was given to pregnant rats and rabbits, it increased the risk of bone problems and miscarriages and decreased the chance of survival in the newborns. Normal Zerit dosages did not appear to cause any problems.
 
Zerit has not been adequately studied in pregnant women. However, there have been a few cases of lactic acidosis and hepatic steatosis in women who took Zerit during pregnancy. Be sure to watch for any signs of these conditions, including:
 
  • Feeling tired or weak
  • Muscle pain
  • Trouble breathing
  • Abdominal pain (stomach pain)
  • Feeling cold
  • Cold or blue hands and feet
  • Dizziness or lightheadedness
  • A slow or irregular heartbeat
  • Persistent nausea, vomiting, and abdominal pain
  • Shortness of breath
  • An enlarged or tender liver
  • Weight loss.
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(Zerit and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;