Marqibo and Pregnancy
Marqibo (liposomal vincristine) may not be safe for women who are expecting. Although the drug has not been adequately studied in pregnant women, it appeared to cause miscarriages, birth defects, and other complications in animal studies. Due to the potential risks, women are usually advised to use an effective form of birth control during Marqibo treatment to avoid pregnancy.
Marqibo® (liposomal vincristine sulfate) is a prescription chemotherapy medication used in the treatment of acute lymphoblastic leukemia (ALL), a type of blood and bone marrow cancer. It is a pregnancy Category D medication, meaning it may harm an unborn child.
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 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, Marqibo caused several problems when given to pregnant rats, including miscarriages, defects of the bone and internal organs, and low fetal weights. The active ingredient in Marqibo, vincristine, has also been shown to cause miscarriages and birth defects when given to pregnant mice, hamsters, and monkeys.
Marqibo has not been adequately studied in pregnant women. There have been case reports describing the use of vincristine in pregnant women. In these reports, babies born to women treated with vincristine during pregnancy have been born with birth defects, including heart defects and abnormally formed kidneys. The drug has also been associated with miscarriages.
It should be noted, however, that in all of the reported cases, the pregnant women were being treated with other chemotherapy medicines in addition to vincristine. Therefore, it is difficult to know whether the problems were due to vincristine, the other medicines, or something else.
Because of the potential risks to an unborn child, Marqibo is generally not recommended for use in expectant mothers. Women of childbearing potential should use an effective form of birth control to avoid becoming pregnant during treatment with Marqibo. Talk to your healthcare provider about the best birth control options for your particular situation.