Diabetes Home > Bydureon and Pregnancy
When the active ingredient in Bydureon (extended-release exenatide) was given to pregnant animals, it appeared to increase the risk for skeletal abnormalities, cleft palates, and reduced fetal growth. Because of these potential risks, Bydureon is classified as a pregnancy Category C medication. However, in some cases, the benefits of the drug may outweigh the potential risks.
Can Pregnant Women Use Bydureon?Bydureon™ (extended-release exenatide) is a prescription injectable drug used to treat type 2 diabetes. Based on the results of animal studies, Bydureon may not be safe for use during pregnancy.
What Is Pregnancy Category C?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 used during pregnancy. Bydureon is classified as a pregnancy Category C drug.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant animals, the active ingredient in Bydureon reduced fetal growth and caused skeletal abnormalities and cleft palates. Also, it increased the risk of death in the newborns.
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 C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.