In animal studies on Mirapex (pramipexole) and pregnancy, the medication impaired implantation and increased the risk of early miscarriages when it was given to pregnant rats. However, the drug has not been studied in pregnant humans, so it is unknown if it is safe for use during pregnancy. If you are taking Mirapex and pregnancy occurs, let your healthcare provider know.
Mirapex and Pregnancy: An Overview
Mirapex® (
pramipexole dihydrochloride) is a prescription medication approved to treat Parkinson's disease and
restless legs syndrome (
RLS). Animal studies indicate that Mirapex may cause problems when used during pregnancy, although the full risks to humans are not known at this time.
Mirapex 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, Mirapex 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 Mirapex. 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.
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