Cancer Home > Alkeran and Pregnancy

The chemotherapy drug Alkeran (melphalan) may not be safe for use during pregnancy. Alkeran has not been studied in pregnant women; however, animal studies have shown that this drug caused miscarriages, birth defects, and other complications when given to pregnant rats. It is generally recommended that women use an effective form of birth control during Alkeran treatment.

Can Pregnant Women Use Alkeran?

Alkeran® (melphalan) is a prescription chemotherapy medicine. It belongs to a group of medicines known as alkylating agents. This product is considered a pregnancy Category D medicine, which means it may cause harm to an unborn child if taken 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, Alkeran caused miscarriages and a variety of birth defects when given to pregnant rats. Birth defects included malformations of the brain, eyes, jawbone, and tail.
This drug has not been adequately studied in pregnant women. However, it is similar to other medications that have been reported to cause problems in the developing fetus when given during pregnancy, including birth defects such as missing fingers and toes and abnormally formed or completely missing kidneys.
Women of childbearing potential should use an effective form of birth control to avoid becoming pregnant during Alkeran treatment. It should be noted that this medication can cause irregular menstrual cycles. If you stop having monthly periods during Alkeran treatment, you should still use an effective form of birth control, as you could still become pregnant. Talk to your healthcare provider about the best forms of birth control to use during your treatment.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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