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Onglyza and Pregnancy

In clinical studies on pregnancy and Onglyza, the medication did not cause any birth defects when it was given to pregnant animals. However, animals do not always respond to drugs the same way that humans do. Before taking this product, pregnant women should first consult their healthcare providers to discuss any potential risks.

Is Taking Onglyza While Pregnant Safe?

Onglyza (saxagliptin) is a prescription diabetes medication. Although the full risks are currently unknown, it appears that this medication is probably safe for use during pregnancy.

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.
Animal studies suggest that this drug is probably safe for use during pregnancy. The medicine did not cause birth defects in animals. However, exceptionally high doses of Onglyza (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.
Because Onglyza is a relatively new medication, there is little experience with this drug in pregnant women. Because animal studies do not always accurately predict what may happen in humans, your healthcare provider may decide to use a medication that has been more widely used in pregnant women.

Final Thoughts on Pregnancy and Onglyza

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. He or she will consider both the benefits and risks of using Onglyza during pregnancy before making a recommendation for your particular situation.
(Click Diabetes and Pregnancy for more information on this topic.)
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