SAFETY ALERT: Possible Heart Failure Risk with Mirapex

The FDA notified healthcare professionals about a possible increased risk of heart failure with Mirapex (pramipexole tablets; Boehringer Ingelheim).

Results of recent studies suggest a potential risk of heart failure that still require further review. The FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure was more frequent with Mirapex vs. placebo. In addition, the FDA evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with Mirapex. It has not been determined yet whether excess heart failure was related to Mirapex use or other factors. The FDA has not concluded that Mirapex increases the risk of heart failure. Healthcare professionals are recommended to follow the drug label when prescribing Mirapex.

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

For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm320054.htm?source=govdelivery.