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Kombiglyze XR and Pregnancy

Although Kombiglyze XR (saxagliptin/metformin ER) has not been studied specifically in pregnant women, the individual components have been studied in pregnant animals. Based on the results of these studies, Kombiglyze XR is probably safe for use during pregnancy. However, because it is still a relatively new drug, your healthcare provider may choose to use an older, more well-known diabetes drug instead.

Can Pregnant Women Use Kombiglyze XR?

Kombiglyze™ XR (saxagliptin/metformin ER) is a prescription diabetes medication. Although the full risks are currently unknown, it appears that this medication is probably 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. 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.
Animal studies suggest that saxagliptin (one of the components of Kombiglyze XR) is probably safe for use during pregnancy. Saxagliptin did not cause birth defects in animals. However, exceptionally high doses (up to 7,986 times the standard equivalent human dose) did cause some problems, such as low fetal weight, minor skeletal variations, and, at the highest doses, unspecified maternal toxicity.
Metformin, the other component, is also generally considered safe for use during pregnancy. In fact, it has actually been used quite a bit in pregnant women (see Metformin and Pregnancy).
Because saxagliptin is a relatively new medication, there is little experience with Kombiglyze XR in pregnant women. In addition, animal studies do not always accurately predict what may happen in humans, so your healthcare provider may decide to use a medication that has been more widely used in pregnant women.
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Kombiglyze XR Medication Information

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