Sinemet CR (carbidopa-levodopa CR) may not be safe to use during pregnancy. Animal studies have indicated that Sinemet CR may decrease the number of live births and increase the risk of various birth defects. However, a pregnant woman may take the medicine if her healthcare provider believes that its benefits outweigh the risks to her unborn child. If you are taking Sinemet CR and pregnancy occurs, let your healthcare provider know.
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 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, short-acting Sinemet decreased the number of live pups born. When given to pregnant rabbits, short-acting Sinemet increased the risk of various birth defects. It is presumed that Sinemet CR would cause similar problems (compared to short-acting Sinemet).
It is important to keep in mind 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 her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. Sinemet CR has not been adequately studied in humans, and there have only been a few cases in which women took Sinemet CR during pregnancy (as Parkinson's disease is rare in young women). In these few reported cases, Sinemet CR did not appear to cause any problems.
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