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FDA Warns of Possible Risk of Heart Failure in Patients Treated With Pramipexole

The U.S. Food and Drug Administration (FDA) issued a Drug Safety Warning for pramipexole (Mirapex), used to treat Parkinson's disease and restless leg syndrome, due to a possible increased risk of heart failure. Recent studies indicate the potential for increased risk. "However, study limitations make it difficult to determine whether excess heart failure was related to Mirapex use or other influencing factors," the warning noted. Given these findings, the Agency cited the need for additional review of data.

The FDA advises health care professionals to continue following the recommendations included on the drug's label and patients should continue to take pramipexole as directed. Any adverse events should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

The FDA will provide updates as they become available. Stay tuned to CardioSource.org and follow @Cardiology on Twitter for the latest FDA updates. To receive immediate FDA-approved cardiovascular drug alerts and related safety information, visit www.ACC.pdr.net. Registration is free for ACC members.