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Jentadueto and Pregnancy

The FDA has categorized Jentadueto (linagliptin/metformin) as a pregnancy Category B medication, meaning that the drug is probably safe to take during pregnancy. When the two active ingredients in this product were given to pregnant animals, the metformin component did not appear to cause fetal harm. However, extremely high doses of linagliptin did cause some problems, such as miscarriages and developmental delays.

Can Pregnant Women Take Jentadueto?

Jentadueto™ (linagliptin/metformin) is a prescription diabetes medication. It appears that this medication is probably safe for use during pregnancy, although the full risks are currently unknown.

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. Jentadueto is classified as a pregnancy Category B medication.
Pregnancy Category B is given to medicines that have not been studied in pregnant humans but do not appear to cause fetal harm in animal studies.
Animal studies suggest that linagliptin (one of the two active ingredients in Jentadueto) is probably safe for use during pregnancy, as it did not appear to cause birth defects. However, exceptionally high doses of the drug (up to 1,943 times the standard equivalent human dose) did cause some problems, such as:
  • Minor skeletal variations
  • Miscarriages
  • Low offspring body weight
  • Developmental delays in the offspring.
These problems are probably the result of maternal toxicity, as the doses used were high enough to cause problems in the mothers.
Metformin (the other component) is also generally considered safe for use during pregnancy. In fact, this drug has been used quite often in pregnant women (see Metformin and Pregnancy).
Because linagliptin is a relatively new medication, there is a lack of experience with using Jentadueto in pregnant women. Animal studies do not always accurately predict what may happen in humans; thus, your healthcare provider may decide to use a medication that has been more widely used in pregnant women.
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Jentadueto Medication Information

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