Alzheimers Home > Namenda XR and Pregnancy

The FDA has classified Namenda XR (memantine XR) as a pregnancy Category B medication, which means that the drug appears to be safe for use during pregnancy. In animal studies, this medicine did not appear to cause serious harm to the fetus. However, a healthcare provider should only prescribe Namenda XR to a pregnant woman if the benefits outweigh the risks.

Can Pregnant Women Take Namenda XR?

Namenda XR® (memantine XR) is a prescription medication approved to treat Alzheimer's disease. Based on animal studies, Namenda XR appears to be safe for use during pregnancy. However, this medication has not been adequately studied in pregnant women.
 

What Is Pregnancy Category B?

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 B is given to medicines that have not been adequately studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies.
 
In addition, medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are also given a Category B rating.
 
In animal studies, memantine (the active ingredient in Namenda XR) did not cause serious problems when given to pregnant rats and rabbits. Slight maternal toxicity (minor problems in the mother), low offspring weight, and minor bone variations were seen at high doses.
 
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 B drug should be given to a pregnant woman only if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
It is important to note that Namenda XR is approved only for the treatment of Alzheimer's disease, a condition that is not likely to occur in women of childbearing age.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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