FDA Warns of Possible Heart Failure Risk with Pramipexole

news.The FDA is investigating the possibility that pramipexole (Mirapex) increases the risk for heart failure.In a pooled analysis of randomized trials, the drug — used to treat Parkinson disease and restless legs syndrome — showed an increased incidence of heart failure relative to placebo, but the results weren't statistically significant. Further review of two epidemiologic studies also found an...

Parkinson's Drug Mirapex Under Safety Review

Parkinson's Disease and Restless Legs Syndrome Drug Under Review for Heart Failure RiskOfficials say recent studies suggest a potential raised risk of heart failure with the use of Mirapex, but further review of research is needed.The FDA's safety alert stops short of an official warning announcement for the drug. The agency has not concluded that Mirapex raises the risk of heart failure.Instead, the...