Comtan and Pregnancy

In clinical studies on Comtan (entacapone) and pregnancy, the medication increased the risk of birth defects, miscarriages, and low birth weight when it was given to pregnant animals. Due to these potential risks, Comtan should only be prescribed to a pregnant woman if the benefits outweigh any possible risks. If you are taking Comtan and pregnancy occurs, let your healthcare provider know immediately.

 

Comtan and Pregnancy: An Overview

Comtan® (entacapone) is a prescription medication approved to treat Parkinson's. Animal studies indicate that the drug may cause problems when used during pregnancy, although the full risks to humans are not known at this time. It should be noted that Comtan 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).
 

Comtan 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.
 
Comtan caused problems in animal studies, increasing the risk of birth defects (including birth defects of the eyes), miscarriages, and low birth weight.
 
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.
 
(Comtan and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;