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Janumet XR and Pregnancy

In general, Janumet XR (sitagliptin and metformin extended-release) is considered safe to take during pregnancy. As a pregnancy Category B medication, it did not appear to cause significant birth defects to the fetus in animal studies. However, you should talk to your healthcare provider about the benefits and risks in your particular situation.

Can Pregnant Women Take Janumet XR?

Janumet® XR (sitagliptin and metformin extended-release) is a prescription diabetes medication. It contains two diabetes medicines: sitagliptin (Januvia®) and metformin ER (Glucophage XR®, Glutametz®, and Fortamet®). Based on animal studies, Janumet XR is generally considered safe for use during pregnancy.

What Is Pregnancy Category B?

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. Janumet XR is classified as a pregnancy Category B medicine.
Pregnancy Category B is given to medicines that have not been adequately studied in pregnant women but do not appear to cause harm to the fetus in animal studies. Medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are also given a Category B rating.
Janumet XR has not been studied in pregnant women. The two medications it contains have also not been studied in pregnant women. However, they have been studied in pregnant rats and rabbits.
Metformin (one of the active components in Janumet XR) did not appear to cause birth defects or other problems when given to pregnant rats and rabbits. In addition, there have been several reports of women taking metformin during pregnancy without major birth defects or other problems occurring.
Sitagliptin (the other active component of Janumet XR) increased the risk for rib malformation when given in very high doses to pregnant rats and rabbits (100 times the maximum recommended human dose). These very high doses also decreased the baby rats' and rabbits' body weights when given throughout pregnancy and during breastfeeding to mother rats. Sitagliptin did not appear to cause birth defects or other problems at lower 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 B medicine, including Janumet XR, should be given to a pregnant woman only if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
While Janumet XR may be considered generally safe for use during pregnancy, many experts recommend pregnant women be treated with insulin for the most effective blood sugar control. In addition, insulin does not cross the placenta to the developing fetus.  
If you have diabetes, it is important to work closely with your healthcare provider if you are thinking of becoming pregnant, and during your pregnancy. Poor blood glucose control can harm you and your unborn child, even before you realize you are pregnant. Therefore, you will need to discuss with your healthcare provider the best ways to monitor and control your blood glucose while you are trying to become pregnant, and throughout your pregnancy.
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Janumet XR Medication Information

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