Xeljanz and Pregnancy
In animal studies, high doses of Xeljanz (tofacitinib) increased the risk for various birth defects and fetal death. Due to the potential risks, this drug has been classified as a pregnancy Category C medication. This means that Xeljanz may harm an unborn child and should only be used when the benefits to the mother outweigh the risks to the unborn child.
Xeljanz® (tofacitinib) is a prescription medication used to treat people with a condition known as rheumatoid arthritis. Based on animal studies, this medicine 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. Xeljanz 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.
In animal studies, Xeljanz increased the risk of birth defects and fetal death when given to pregnant rats and rabbits at extremely high doses.
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 Xeljanz, 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.
If you are pregnant or thinking of becoming pregnant while using Xeljanz, let your healthcare provider know. He or she will consider both the benefits and risks before making a recommendation in your particular situation.