Gleevec and Pregnancy
The chemotherapy drug Gleevec (sunitinib) has been given a pregnancy Category D rating by the FDA. This means that it is generally not recommended for use during pregnancy. In animal studies, the drug was shown to increase the risk of miscarriage and fetal malformation. However, sometimes the benefits will significantly outweigh the risks, and the medication will be prescribed to a woman who is pregnant.
Gleevec® (imatinib mesylate) is a prescription medication used to treat people with certain types of cancer. This medication may cause fetal harm if used during pregnancy.
What Is Pregnancy Category D?
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when 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 the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
In animal studies, the drug increased the risk for neural tube defects and defects of bones in the head when given to pregnant rabbits at doses approximately equal to the maximum recommended human dose. Miscarriages also occurred in the pregnant rats, even at low doses (about half the maximum recommended human dose). Doses higher than the maximum recommended human dose caused total fetal loss in the rats.
Gleevec has not been adequately studied in pregnant women. There have been reports, however, of women who took the medicine in their pregnancy. Some of the infants were born without any birth defects or other problems, while some others were born with birth defects. One particular type of defect did not stand out, however.
Gleevec is generally not recommended for use in pregnant women. There is little information available about the drug during pregnancy in humans, aside from the case reports. However, based on the results of animal studies, and the known actions of the medicine, it may cause harm to a developing baby if taken by a pregnant woman.
There may be cases when a pregnant woman is given Gleevec. For example, if no other treatment options exist, the benefits of using the medicine to treat cancer may outweigh the possible risks to the unborn child.
Women of childbearing potential should avoid becoming pregnant during Gleevec treatment by using an effective form of birth control. Your healthcare provider can provide you with more information on effective birth control options during Gleevec treatment.