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Gralise and Pregnancy

Animal studies on the active ingredient in Gralise (extended-release gabapentin) suggest that the drug may not be safe for women to take when pregnant. In these studies, the drug increased the risk for miscarriages and caused problems in the kidneys and urinary tract. However, your healthcare provider may prescribe this drug if the benefits outweigh the possible risks.

Can Pregnant Women Take Gralise?

Gralise™ (extended-release gabapentin) is a prescription medication used to treat postherpetic neuralgia (nerve pain after a case of shingles). Based on the results of animal studies (which may not reflect the true risks for humans), the drug 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 taken during pregnancy. 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.
Studies of gabapentin (the active ingredient in Gralise) in pregnant rodents suggest that the drug may delay the growth and development of the fetus, especially affecting the bones. When given to pregnant rats, gabapentin caused problems in the kidneys and urinary tract. When given to pregnant rabbits, the drug increased the risk for miscarriages.
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 the healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
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Gralise Medication Information

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