Topotecan and Pregnancy

Animal studies on topotecan (Hycamtin) have shown that this chemotherapy drug could cause potential problems (such as birth defects and miscarriages) in a fetus. Due to these potential risks, the FDA has classified topotecan as a pregnancy Category D medicine, meaning it is generally not safe for pregnant women.

Can Pregnant Women Use Topotecan?

Topotecan (Hycamtin®) is generally considered unsafe for use during pregnancy. In animal studies that looked at the effects of this drug during pregnancy, topotecan caused both miscarriages and birth defects.
 

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 given to medicines that have shown clear evidence of risk to the fetus in studies. Pregnancy Category D is a stronger warning than a pregnancy Category C classification. However, a pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
 
Topotecan was given a pregnancy Category D rating because of problems in animal studies. When given to pregnant animals, topotecan increased the risk of miscarriages and a variety of different birth defects, some quite severe. There is also concern that topotecan could increase the risk of cancer in offspring.
 
Although the potential for serious problems appears to be rather high, this drug was assigned a pregnancy Category D rating (instead of a Category X rating, which would usually be most appropriate), because it is used to treat potentially fatal cancers. In other words, although the risks are probably quite high, the benefits are also potentially very great.
 
There are no reports on the use of topotecan during human pregnancy.
 
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Topotecan Chemotherapy Information

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