Epilepsy Home > Diastat and Pregnancy

In studies that looked at the effects of diazepam (the active ingredient in Diastat) and pregnancy, the drug increased the risk of birth defects and other problems. As a result, Diastat has been classified as a pregnancy Category D medication by the FDA. However, if you are taking Diastat and pregnancy occurs, your healthcare provider may have you continue taking it if the benefits outweigh the risks.

Diastat and Pregnancy: An Overview

Diastat® (diazepam rectal gel) is generally considered unsafe for use in pregnant women. In animal studies and a few human studies that looked at the effects of diazepam (the active ingredient in Diastat) during pregnancy, the drug caused birth defects and other problems.

Diastat and Pregnancy Category D

The U.S. Food and Drug Administration (FDA) uses a system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is given to medicines that have shown clear evidence of risk to the fetus in studies. This is a stronger warning than a pregnancy Category C classification. However, a pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the risks to the unborn child.
Diastat was given a pregnancy Category D rating because of problems with other forms of diazepam in animal and human studies. These studies suggested that diazepam may increase the risk of various birth defects and may cause other problems, such as withdrawal symptoms after an infant is born. However, this is a controversial issue, since some studies have shown that the risk of birth defects may be small.
In any case, it is important to remember that uncontrolled seizures are also dangerous during pregnancy. For many women, the benefits of using Diastat while pregnant may outweigh the risks. The medication should be used during pregnancy only when necessary.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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