Januvia and Pregnancy
The FDA has classified Januvia as a pregnancy Category B medication, meaning that the medicine does not appear to cause harm to the fetus in animal studies. It is important to note, however, that animals do not always respond to medicines in the same way that humans do, and the full risks of taking Januvia during pregnancy are not known. Therefore, be sure to talk to your healthcare provider about Januvia and pregnancy.
Januvia® (sitagliptin) is generally considered safe for women who are pregnant. In animal studies that looked at the effects of Januvia during pregnancy, the drug did not appear to have adverse effects.
Januvia and Pregnancy Category B
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies.
While a pregnancy Category B medication did not appear to have adverse effects in animal studies, it's important to remember that animals do not always respond to medicines the same way that humans do. Therefore, a healthcare provider recommending a pregnancy Category B medicine to a pregnant woman still has to weigh the potential benefits of the drug against any possible risks to the unborn child.
In studies, very high doses of Januvia did not cause any fertility problems and did not cause any harm in pregnant rats and rabbits. As mentioned above, however, animals do not always respond to medicines in the same way that humans do. Furthermore, because the medication has not been studied in pregnant women, the full risks of using Januvia in pregnant women are not known.