The FDA is investigating a possible risk of heart failure linked to Mirapex, a drug used to treat Parkinson’s disease and restless legs syndrome.
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
The alert comes after the FDA pooled results from clinical trials, and analysis suggests heart failure was more common among people taking Mirapex than those taking a placebo.
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.
Officials recommend people taking the drug contact a health care professional if they experience any symptoms of heart failure while taking Mirapex, such as:
- Shortness of breath — with exercise or at rest
- Swelling of the feet, ankles, legs, or abdomen
- Fatigue and weakness
- Rapid or irregular heartbeat
- Chest pain
- Persistent cough or wheezing with white or pink blood-tinged phlegm