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Based on animal studies on glyburide and pregnancy, the FDA has classified DiaBeta as a pregnancy Category C medication and Glynase, Micronase, and generic glyburide as pregnancy Category B medications. While these medications all contain the same active ingredient, different results were seen in animal tests. If you are taking glyburide and pregnancy occurs, your healthcare provider will weigh the benefits and risks before making a recommendation.
Glyburide and Pregnancy: An OverviewGlyburide (DiaBeta®, Glynase®, or Micronase®) may not be safe for women to take during pregnancy. This is based on animal studies that looked at the effects of the drug on pregnancy. However, the safety of glyburide use during pregnancy is a complex issue.
Glyburide and Pregnancy Categories B and CThe 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. DiaBeta has been classified as a pregnancy Category C medication. Glynase, Micronase, and generic glyburide have been rated as pregnancy Category B medications. At first thought, this seems impossible, since all three products contain the same active ingredient in similar amounts.
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that appear to cause harm to the fetus based on animal studies. Pregnancy Category B medications have not been studied in pregnant women either, but they do not appear to cause harm to the fetus based on animal studies. It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B or Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child.