Mirapex ER and Pregnancy
The FDA has classified Mirapex ER (pramipexole ER) as a pregnancy Category C medication, meaning that it may not be safe for pregnant women to take it. Animal studies indicate that this medicine may increase the risk of early miscarriages. However, if the benefits outweigh the risks, a healthcare provider may decide to prescribe this drug to a pregnant woman.
Is Mirapex ER Safe During Pregnancy?Mirapex® ER™ (pramipexole ER) is a prescription Parkinson's disease medication. Animal studies suggest that this drug may cause problems when used during pregnancy, although the full risks to humans are not known at this time.
What Is Pregnancy Category C?The U.S. Food and Drug Administration (FDA) uses a pregnancy 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, pramipexole (the active ingredient in Mirapex ER) impaired implantation (the process of a fertilized egg implanting in the uterus) and increased the risk of early miscarriages. These problems may be related to the prolactin-lowering effects of pramipexole. Prolactin is necessary for implantation and early pregnancy in rats, but not in humans, so this may not be a problem for humans.
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.