Byetta and Pregnancy
Because Byetta does appear to cause harm to the fetus in animal studies, the FDA has classified Byetta as a pregnancy Category C medication. When Byetta was given to pregnant mice, it reduced the growth of the baby mice and caused birth defects, especially skeletal problems. Byetta also increased the death rate in the baby mice. Therefore, be sure to talk to your healthcare provider about the risks of Byetta and pregnancy.
For people who are pregnant, Byetta® (exenatide) may not be safe. This is based on animal studies that looked at the effects of Byetta during pregnancy.
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 C is given to medicines that have not been studied in pregnant humans, but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant mice, Byetta reduced the growth of the baby mice and caused birth defects (especially skeletal problems) in the mice. Also, Byetta increased the death rate in the baby mice. It is important to note though 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 the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider both the benefits and the risks of taking Byetta during pregnancy before making a recommendation for your particular situation.
(Click Diabetes and Pregnancy for more information on this topic.)