The FDA has notified healthcare professionals about a possible increased risk of heart failure with pramipexole (Mirapex, Boehringer Ingelheim); however, the agency stressed that the results of these recent studies need further review.
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. The FDA has 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.
The agency also evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with Mirapex use; however, the study's limitations made it difficult to determine whether excess heart failure was related to Mirapex use or other influencing factors.
Pramipexole is 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.
At this time, the FDA has not concluded that Mirapex increases the risk of heart failure; however, the agency noted that 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," the safety alert stated.