Sprycel and Pregnancy
In animal studies on Sprycel (dasatinib), the drug caused miscarriages and abnormal bone development when given to pregnant rats and rabbits. As a result, the FDA has classified it as a pregnancy Category D medication, meaning this drug could cause fetal harm. However, there may be circumstances in which the benefits of using Sprycel outweigh the possible risks to the fetus.
Sprycel® (dasatinib) is a prescription medication approved for use in the treatment of leukemia. As a pregnancy Category D medication, Sprycel may harm an unborn baby if taken by a pregnant woman.
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 the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Sprycel has not been adequately studied in pregnant women. It has been studied in rats and rabbits. In these animal studies, the drug caused miscarriages when given to pregnant rats, even at low doses. It also caused other problems in the baby rats and rabbits, including abnormal bone development at many different sites (such as the legs, arms, and ribs) and an abnormally small liver.
Women who are taking Sprycel should avoid becoming pregnant by using an effective form of birth control. In general, women who are pregnant should not use this medicine unless the benefits of use outweigh the potential harm to the unborn baby. This could be the case if Sprycel is the only treatment option available for a pregnant woman.