Mirapex (pramipexole): Possible Increased Risk of Heart Failure

The US FDA notifies Neurologists that Mirapex (pramipexole) may be associated with increased risk of heart failure.

Background of Mirapex

Mirapex (pramipexole) belongs in a class of medicines called dopamine agonists. It is a prescription drug for the treatment of moderate to severe symptoms of primary restless legs syndrome and the treatment of signs and symptoms of Parkinson’s disease.

FDA Alert on Mirapex

The FDA, after evaluation of a pooled analysis of randomized clinical trials, found that the incidence of heart failure with Mirapex was higher than with placebo but with no statistical significance.

Two epidemiologic studies evaluated by the FDA indicated increased risk of new onset of heart failure with Mirapex use. Nevertheless, the limitations of the study made it difficult to determine whether these findings were related to Mirapex use or other factors.

The agency is working to clarify further the risk of heart failure with Mirapex and will update the public when more information is available.

Recommendation on Mirapex

“At this time, FDA has not concluded 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 continue to take their Mirapex as directed and should contact their health care professional if they have any questions or concerns.”

Contacting the FDA to report cases with Mirapex

In case of detection of adverse events or side effects related to the use of Mirapex, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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