Nuedexta and Pregnancy
In studies on Nuedexta (dextromethorphan and quinidine), miscarriages, developmental delays, and reduced body weight occurred in the offspring when the drug was given to pregnant animals. However, this medicine has not been studied in pregnant women. Therefore, Nuedexta should only be given during pregnancy if the benefits to the mother outweigh the risks to the unborn child.
Nuedexta™ (dextromethorphan and quinidine) is a prescription medication licensed to treat pseudobulbar affect (PBA), or sudden, involuntary episodes of uncontrolled laughing or crying. Based on the results of animal studies, this medication may not be safe for use in pregnant women.
Nuedexta is classified as a pregnancy Category C drug. 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.
Nuedexta has not been studied in pregnant women. In animal studies, this drug was shown to cause miscarriages and birth defects. When given to pregnant rabbits, high doses of Nuedexta caused miscarriages; lower doses caused problems with fetal bone development. When Nuedexta was given to rats during pregnancy and while breastfeeding, it resulted in lower survival rates, reduced body weights, and developmental delays.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, pregnancy Category C medicines, including Nuedexta, may be given to a pregnant woman if her healthcare provider believes that the benefits of the medication outweigh any possible risks to her unborn child.