The US Food and Drug Administration (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.
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 healthcare professional if they have any questions or concerns.
Additional Information for Patients
- Do not stop taking your Mirapex unless told to do so by your healthcare professional.
- 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.
- Talk to your healthcare professional if you have any questions or concerns about Mirapex.
- Contact your healthcare professional if you experience any symptoms of heart failure while taking Mirapex, such as shortness of breath – with exercise or at rest; swelling of the feet, ankles, legs, or abdomen; fatigue and weakness, rapid or irregular heart beat; chest pain; or persistent cough or wheezing with white or pink blood-tinged phlegm. Patients have reported swelling of the ankles and/or feet without other signs of heart failure while taking Mirapex.
- Report side effects from Mirapex to FDA’s MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.
Facts about Mirapex (pramipexole)
- A prescription medicine used to treat the signs and symptoms of Parkinson's disease and moderate to severe symptoms of primary restless legs syndrome
- In a class of medicines called dopamine agonists
- Works by acting in place of dopamine, produced by specific areas of the brain that control movement. Parkinson's disease causes progressive loss of dopamine production in the brain.
This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs.
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