October 3, 2012

FDA Suspects Mirapex Is Linked to Heart Failure
But Jury Is Still Out

Washington, D.C.—The FDA is alerting health professionals to a possible increased risk of heart failure with Mirapex (pramipexole), which is used to treat Parkinson’s disease and restless legs syndrome.

Results of recent studies suggest a potential risk of heart failure, but, because of study limitations, further review of available data is required, the FDA says.

FDA cites a pooled analysis of randomized clinical trials that found heart failure was more frequent with the dopamine agonist than with placebo, but it cautions that the results were not statistically significant. Two epidemiologic studies suggesting an increased risk of new-onset heart failure with Mirapex use were inconclusive because of the difficulty of determining whether excess heart failure was related to Mirapex or other factors.

A case-control study published this past spring, using data from four population-based European databases of 38,641 patients with Parkinson’s disease, found that among individual nonergot dopamine agonists, only current use of Mirapex was associated with an increased risk of heart failure when compared to levodopa (odds ratio [OR] = 1.61; 95% CI: 1.09-2.38).

The increased risk for heart failure was indicated within the first 3 months of therapy (OR = 3.06; 95% CI: 1.74-5.39) and in patients aged 80 years and older (OR = 3.30; 95% CI: 1.62-7.13). The increased risk for heart failure was not significant in those who used Mirapex longer than 3 months, however.

The earlier epidemiologic study suggested that current use of any dopamine agonist versus no use of a dopamine agonist was associated with a statistically significant increase in risk for heart failure (risk ratio [RR] = 1.58; 95% confidence interval [CI]: 1.26-1.96). That study also found a statistically significant association for Mirapex (RR = 1.86; 95% CI: 1.21-2.85) and cabergoline (RR = 2.07; 95% CI: 1.39-3.07), compared to those who did not use those drugs.

The FDA says pharmacists and other health care professionals should continue to follow drug label recommendations and should urge patients to continue to take Mirapex as directed. Further guidance will be provided when available, according to the Drug Safety Communication.

Health professionals are encouraged to discuss the benefits and potential risks of Mirapex with patients and to counsel them to get medical help if they exhibit any heart failure symptoms.

FDA asks that adverse events involving Mirapex be reported to FDA’s MedWatch program.

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