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Apidra and Pregnancy

Apidra (insulin glulisine) has not been adequately studied in pregnant women, so it is not known if it is safe to take this medication during pregnancy. Apidra did not appear to increase the risk of any problems in the fetus when used in animal studies. Although Apidra is considered a pregnancy Category C medication, some healthcare providers feel comfortable recommending this drug during pregnancy.

Apidra During Pregnancy: An Overview

Apidra® (insulin glulisine) is a prescription diabetes medication used to treat type 1 and type 2 diabetes. It is a rapid-acting form of insulin used to control blood sugar after meals. At this time, it is not clear if Apidra (or any of the newer insulins) is safe for use during pregnancy. Some healthcare providers are comfortable recommending Apidra for pregnant women, while others are not.

Apidra and 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 taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that 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 "default" pregnancy Category C rating.
In animal studies, Apidra was compared to regular human insulin (one of the standard forms of insulin often recommended for pregnant women). Apidra did not appear to increase the risk of any problems, compared to regular human insulin. In general, any problems that were seen were caused by low blood sugar in the mother animals. However, the drug has not been adequately studied in pregnant women. Although it was thought that insulins do not cross the placenta, it is now known that some insulins, in some circumstances, may cross over.
Some healthcare providers are uncomfortable recommending any of the newer insulins that have not been studied in pregnant women, including Apidra. However, many healthcare providers make the logical assumption that the new insulins are just as safe (and usually more convenient) than the older insulins. This is a decision you and your healthcare provider must make together.
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