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.
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