DTIC-Dome and Pregnancy
Women who are undergoing chemotherapy treatment with DTIC-Dome (dacarbazine) should be aware of the potential risks this drug may pose to an unborn child. A pregnancy Category C medicine, DTIC-Dome appeared to cause a variety of bone, brain, and spinal cord defects during animal studies. This medicine should only be used during pregnancy if the benefits to the mother outweigh the risks to the fetus.
DTIC-Dome® (dacarbazine) is a prescription medication given as an injection to treat certain types of cancer. Based on the results of animal studies, DTIC-Dome may not be safe for use during pregnancy.
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. DTIC-Dome is classified as a pregnancy Category C medicine.
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
DTIC-Dome caused birth defects, such as defects of the bone, brain, and spinal cord, when given to pregnant rats in very high doses. It also caused bone defects in the offspring when given in high doses to pregnant rabbits. This medication has not been adequately studied in pregnant humans.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine, including DTIC-Dome, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.