Product News and Recalls

FDA warns about heart failure from drug

The FDA has notified healthcare professionals about a potential increased risk of heart failure from the drug pramipexole, which is sold under the brand name Mirapex.

Mirapex is a prescription medicine used to treat Parkinson’s disease and restless legs syndrome.

According to the FDA warning, recent studies suggest a possible increased risk of heart failure from Mirapex, requiring further review of available data. But because of the study limitations, the FDA isn’t able to demonstrate conclusively whether Mirapex increases that risk.

Further announcements may be forthcoming. In the meantime, the FDA recommends that healthcare professionals continue to follow recommendations in the drug label when prescribing Mirapex, and that patients continue to take the drug as directed.

The FDA also recommends that patients contact their health care professional if they have any questions or concerns.

See the notice here:

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