Pramipexole and Possible Risk of Heart Failure

FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure was more frequent with Mirapex (Pramipexole) 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.

Additional Information for Health Care Professionals

- FDA has not concluded that Mirapex increases the risk of heart failure. The Agency is continuing to review this safety concern and will update the public when more information is available.
- Continue to follow the recommendations in the drug label when prescribing Mirapex.
- Discuss the benefits and potential risks of Mirapex with your patients.
- Counsel patients to seek medical attention if they experience symptoms of heart failure while taking Mirapex.
- Report adverse events involving Mirapex to FDA’s MedWatch program using the information in the "Contact FDA" box at the bottom of this page.