The FDA notified healthcare professionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk of heart failure that needs further review of available data.
Due to the study limitations, the FDA is unable to determine at the moment whether Mirapex increases the risk of heart failure, and it is continuing to work with the manufacturer to further clarify the risk of heart failure with Mirapex and will update the public when more information is made available.
The FDA evaluated a pooled analysis of randomized clinical trials and found that the heart failure was more frequent with Mirapex than with placebo; however, these results were not statistically significant. The FDA also evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with use of Mirapex. However, study limitations make it difficult to determine whether excess heart failure was related to use of Mirapex or other influencing factors.
Mirapex is a prescription medicine used to treat the signs and symptoms of Parkinson’s disease and moderate to severe symptoms of primary restless legs syndrome. It belongs to a class of medicines called dopamine agonists.
At this time, the FDA has not reached a conclusion that Mirapex increases the risk of heart failure. Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Mirapex. Patients should also continue to take their Mirapex as directed and should contact their healthcare professional if they have any questions or concerns.