FDA warns of possible heart failure risk with Mirapex

September 19, 2012

FDA notified healthcare professional about a possible increased failure of heart risk with pramipexole (Mirapex).

FDA notified healthcare professionals about a possible increased risk of heart failure with pramipexole (Mirapex).

Mirapex is a non-ergot dopamine agonist indicated to treat the signs and symptoms of Parkinson's disease and moderate to severe symptoms of primary restless legs syndrome.

Results of recent studies suggest a potential risk of heart failure that needs further review of available data. 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.

FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure was more frequent with Mirapex than with a placebo; however, these results were not statistically significant. FDA also evaluated 2 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.

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 healthcare professional if they have any questions or concerns.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Reports can be made online or by calling (800) 332-1088 to request a reporting form, which should be complete and returned to the address on the pre-addressed form, or submitted by fax to (800) FDA-0178.

Read the MedWatch safety alert here, including a link to the FDA Drug Safety Communication.