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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY November 2012 | Archived Issues

FDA conducting ongoing safety review of Mirapex

Pharmacy focus

The U.S. Food and Drug Administration is notifying healthcare professionals about a possible increased risk of heart failure with Mirapex (pramipexole).

Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, the FDA is not able to determine whether Mirapex increases the risk of heart failure. The agency 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.

Mirapex (pramipexole) is a prescription medicine used to treat the signs and symptoms of Parkinson's disease and moderate to severe symptoms of primary restless leg syndrome, in a class of medicines called dopamine agonists.

The FDA is recommending that healthcare professionals 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.

Click here to read the MedWatch safety alert and see a link to the FDA Drug Safety Communication.

Pharmacy and Therapeutics Committee approvals

Cedars-Sinai's P&T Committee released approvals from a recent meeting. Please see the following PDF: Pharmacy and Therapeutics Committee Approvals Aug 2012 (PDF)