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Tradjenta and Pregnancy

Animal studies have suggested that Tradjenta (linagliptin) is probably safe during pregnancy. Tradjenta did not appear to cause problems when given in normal amounts to pregnant animals; however, extremely high doses did cause problems in the offspring. Because Tradjenta is a relatively new drug, a healthcare provider may decide to give you a diabetes medication that is known to be safer for use during pregnancy.

Can Pregnant Women Take Tradjenta?

Tradjenta™ (linagliptin) 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?

Tradjenta is classified as a pregnancy Category B drug. 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 fetal harm in animal studies.
Animal studies suggest that Tradjenta is probably safe for use during pregnancy. Tradjenta did not cause birth defects in animals. However, exceptionally high doses of Tradjenta (up to 1,943 times the standard equivalent human dose) did cause some problems, including:
  • Minor skeletal variations
  • Miscarriages
  • Low body weight in the offspring
  • 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.
Because this is a relatively new medication, there is little experience with Tradjenta use in pregnant women. Animal studies do not always accurately predict what might 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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