September 21, 2012
FDA notified patients and healthcare providers of the possibility of an increase in the risk of heart failure with pramipexole (Mirapex®). It is unknown at this time if pramipexole increases the risk of heart failure, but FDA is conducting an ongoing safety review to evaluate the risk. Pramipexole is a drug used for symptoms of Parkinson’s disease and primary restless legs syndrome.
The notification about possible increased risk of heart failure is based on a pooled analysis of randomized clinical trials and results of 2 epidemiologic studies. The pooled clinical trial data found that patients taking pramipexole had heart failure more often than patients taking placebo; however, the between-group difference was not statistically significant. In one epidemiologic study, the risk of heart failure was increased with pramipexole compared with no pramipexole use. The second epidemiologic study found an increased risk of heart failure with pramipexole compared with levodopa. In this study, increased risk was statistically significant during the first three months of therapy and in elderly patients (≥80 years of age); after the initial 3 months of pramipexole use, the increased risk of heart failure was not statistically significant. It is unclear if pramipexole is the cause of the increased risk of heart failure seen in these studies due to limitations of the studies.
FDA has not concluded that pramipexole increases risk of heart failure, but is working to further clarify available data. The public will be updated when more information becomes available.
Healthcare providers are reminded to follow prescribing recommendations found in the product labeling. Educate patients taking pramipexole on the symptoms of heart failure and counsel them to seek medical attention if symptoms develop. Patients taking pramipexole are instructed to continue taking their medication as instructed by their healthcare provider. Patients should direct any questions regarding pramipexole to their healthcare provider. Report any adverse events to FDA MedWatch program.
Additional information is available at the following links:
- MedWatch Alert:
- Drug Safety Communication:
- Epidemiologic Trials (University of Utah Campus Only)
September 21, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.