Breast Cancer Home > Halaven and Pregnancy

The chemotherapy drug Halaven (eribulin) is generally considered unsafe for use during pregnancy. When low doses were given to pregnant rats, the medication increased the risk for miscarriages and serious birth defects. However, a healthcare provider may still prescribe it during pregnancy if he or she believes the benefits to the pregnant woman outweigh the risks to the unborn child.

I'm Pregnant -- Can I Receive Halaven?

Halaven™ (eribulin mesylate) is a chemotherapy medication approved for the treatment of breast cancer. As with most chemotherapy drugs, Halaven may be harmful to a developing fetus.

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.
Halaven was given a pregnancy Category D rating because of problems in animal studies. When given to pregnant rats, even low doses of Halaven increased the risk for miscarriages, low birth weight, and serious or disfiguring birth defects. Nonetheless, some women will decide to proceed with Halaven treatment during pregnancy, as the medication has the potential be life-saving.
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category D medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.

Final Thoughts

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know before receiving Halaven. He or she will consider the benefits and risks before making a recommendation in your particular situation.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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