FDA Drug Safety Communication

FDA is informing the public about a possible increased risk of heart failure with Mirapex (pramipexole), a drug used to treat Parkinson's disease and restless legs syndrome. Results of recent studies suggest a potential risk of heart failure that needs further review of available data.

FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure was more frequent with Mirapex than with placebo; however, these results were not statistically significant. FDA also evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with Mirapex use. However, study limitations make it difficult to determine whether excess heart failure was related to Mirapex use or other influencing factors.

Because of the study limitations, FDA is not able to determine whether Mirapex increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with Mirapex and will update the public when more information is available.

Health care 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 healthcare professional if they have any questions or concerns.

View the full FDA Drug Safety Communication on FDA.gov