It may not be safe to use Tasmar (tolcapone) during pregnancy. Tasmar has been shown to cause problems, such as miscarriages and problems with growth and learning, when it was given to pregnant rabbits and rats. The FDA has classified Tasmar as a pregnancy Category C medication, which means it could cause problems during pregnancy, although the full risks are not known.
Tasmar and Pregnancy: An Overview
Tasmar® (
tolcapone) is a prescription medication approved to treat
Parkinson's disease. Animal studies indicate that Tasmar may cause problems when used during pregnancy, although the full risks to humans are not known at this time.
Tasmar 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 rabbits, Tasmar increased the risk of miscarriages. When given to rats during pregnancy and lactation (breastfeeding), it decreased litter size and caused problems with growth and learning. It should be noted that Tasmar is never used alone; it is always used in combination with
carbidopa and levodopa products (such as
Sinemet®,
Sinemet CR, or
Parcopa®). Carbidopa and levodopa have also caused problems during pregnancy in animal studies
(see Sinemet and Pregnancy).
However, 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.
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