Toposar and Pregnancy

Serious complications are associated with using Toposar (etoposide injection) during pregnancy. Women who are undergoing treatment with this drug should be aware that this pregnancy Category D medication was shown to cause miscarriages, birth defects, and other problems when given to pregnant animals. This medication should only be given to a pregnant woman if the benefits to the mother outweigh the risks to the fetus.

Can Pregnant Women Receive Toposar?

Toposar® (etoposide injection) is a prescription chemotherapy medication approved to treat certain types of lung and testicular cancer. It is used in combination with other cancer medicines. Toposar is a pregnancy Category D medicine because it may harm an unborn child if used during pregnancy.

What Is Pregnancy Category D?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
In animal studies, Toposar caused a variety of problems when given to pregnant rats and mice. Even at low doses (one-half or less than the usual equivalent human dose) the drug increased the risk for low fetal weight, miscarriage, and birth defects. Some of the birth defects included:
  • Neural tube defects
  • Defects of the bones, skull, and lungs
  • Underdevelopment or complete absence of the eyes.
This drug has not been adequately studied in pregnant women. There have been a few case reports describing pregnancy outcomes in women who received Toposar in the second or third trimester (after the baby's organs have developed). In these reports, Toposar affected fetal growth and caused severe bone marrow suppression in the unborn baby. As a result, some of the infants were born with problems such as:
  • Anemia (decreased red blood cells)
  • Decreased levels of white blood cells
  • Decreased blood platelets.
Because of the potential for fetal harm, this drug is generally not recommended for use in pregnant women. However, because lung cancer is potentially fatal, there may be times when the medication is recommended during pregnancy despite the potential risks.
Women of childbearing age who are receiving Toposar are advised to use an effective form of birth control to avoid pregnancy. You can talk to your healthcare provider about possible birth control options for your situation.
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Toposar Chemotherapy Information

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