Stalevo and Pregnancy

In studies on Stalevo (carbidopa-levodopa-entacapone) and pregnancy, the medication caused problems when it was given to pregnant animals. When given to pregnant rats, carbidopa and levodopa decreased the number of live pups born. Entacapone also caused complications in animal studies, increasing the risk of birth defects, miscarriages, and low birth weight. If you are taking Stalevo and pregnancy occurs, notify your healthcare provider immediately.

 

Stalevo and Pregnancy: An Overview

Stalevo® (carbidopa-levodopa-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.
 

Stalevo 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 rats, carbidopa and levodopa (two of the components of Stalevo) decreased the number of live pups born. When given to pregnant rabbits, carbidopa and levodopa increased the risk of various birth defects. Entacapone (the other component of Stalevo) also caused problems in animal studies, increasing the risk of birth defects, miscarriages, and low birth weight.
 
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.
 
(Stalevo 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;