Animal studies on Campral (acamprosate) and pregnancy have shown the medication may not be safe for use in pregnant women. When given to pregnant rats and rabbits, Campral increased the risk of problems with the kidneys, eyes, and blood vessels in the fetus. If you are taking Campral and pregnancy occurs, your healthcare provider will consider the benefits and risks in your particular situation.
Campral and Pregnancy: An Overview
Campral® (
acamprosate calcium) is a prescription medication approved to treat alcohol dependence. Based on animal studies, the drug may not be safe for use in pregnant women. However, because alcohol use is also unsafe for pregnant women, the potential risks and benefits of using Campral during pregnancy must be considered.
Campral 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 pregnancy Category C rating.
When given to pregnant rats and rabbits, Campral increased the risk of birth defects, including kidney problems, eye problems, and problems with certain blood vessels. However, animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. In many cases, the potential benefits of Campral outweigh the risks, as alcohol itself can be dangerous during pregnancy
(see Alcohol During Pregnancy).