Officials 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 FDA says it is working with Mirapex’s manufacturer to clarify the risk of heart failure and will update the public when more information is available.
Meanwhile, officials say people taking Mirapex should continue to take the drug as prescribed and contact their health care provider with any questions or concerns.
Mirapex Under Review
They also evaluated two population studies that suggested a higher risk of new cases of heart failure among Mirapex users. However, officials say limitations of the studies make it difficult for them to determine whether the risk was related to Mirapex or other factors.
The FDA is continuing to review safety data on Mirapex.