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FDA Says Mirapex May Pose Risk of Heart Failure

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The U.S. Food & Drug Administration (FDA) just announced that Parkinson’s disease medication, Mirapex (pramipexole), may pose increased risks for heart failure. The agency notified health care professionals following release of recent study results.

A Parkinson’s disease drug, Mirapex is also approved to treat the symptoms of moderate to severe primary restless legs syndrome. Mirapex is in the class of drugs called dopamine agonists and works by acting in place of dopamine. Dopamine is produced by specific areas of the brain that control movement; Parkinson’s disease causes progressive loss of dopamine production in the brain.

Recent research suggests a potential risk for heart failure that calls for additional review of current data. The FDA reviewed a collected analysis of randomized clinical trials and discovered that heart failure occurred more often with Mirapex than with a placebo; results were not considered statistically significant. The agency also evaluated two epidemiologic, or population, studies that suggested an increased risk of new onset of heart failure with Mirapex use. In that case, study limitations made it difficult to confirm if excess heart failure was linked to Mirapex or other factors, said WebMD.

WebMD noted that the agency’s safety alert stopped just short of an official warning for Mirapex because it has not yet concluded that the drug raises heart failure risks. The agency did say it was working with the maker of Mirapex to confirm these heart risks.

Healthcare professionals should continue to follow drug label recommendations and patients should continue to take Mirapex as directed and contact their health care professional with questions or concerns, the FDA said. Adverse events or side effects related to the use of Mirapex should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: The reporting form can be downloaded at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm; consumers can also call 1.800.332.1088 to request a reporting form. Complete and return the form to the address on the pre-addressed form, fax the form to 1.800.FDA.0178, or submit the report online at www.fda.gov/MedWatch/report.htm.

The FDA advises patients to contact their health care professionals if any of the symptoms of heart failure are experienced while taking Mirapex. Symptoms include shortness of breath—with exercise or at rest; swelling of the feet, ankles, legs, or abdomen; fatigue or weakness and rapid or irregular heart beat; chest pain; or persistent cough or wheezing with white or pink blood-tinged phlegm. Patients have reported swelling of the ankles and/or feet without other signs of heart failure while taking Mirapex.

NewsInferno previously wrote that lawsuits in the United States involving Mirapex included claims that the medication caused gambling and pornography addictions. In fact, said NewsInferno, a number of studies revealed evidence of an association between dopa agonists and compulsive behaviors. Hundreds of these lawsuits, nationwide, were previously consolidated in a multidistrict litigation in U.S. District Court in Minnesota. In July 2008, a jury awarded $8.2 million in the litigation’s first bellwether trial to a man who became a compulsive gambler after using Mirapex.

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