FDA Warns That Mirapex May Increase Risk of Heart Failure

Boehringer Ingelheim Pharmaceuticals, Inc.

FDA has alerted health care professionals to the possibility that the medication Mirapex (pramipexole) could increase the risk of heart failure. Mirapex is a prescription medicine used to treat the signs and symptoms of Parkinson’s disease and restless legs syndrome.  It is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.

Risk: FDA evaluated an analysis of clinical trials and found that heart failure was more frequent with Mirapex than with a placebo treatment. However, these results were not considered statistically significant. FDA also evaluated two epidemiologic studies that suggested an increased risk of heart failure with Mirapex use. However, study limitations made it difficult to determine the influence of other factors.

Thus FDA has not been able to determine conclusively whether Mirapex increases the risk of heart failure. The agency is working with the manufacturer to clarify the risk and will update the public when more information is available.

At this time, FDA has not concluded that Mirapex increases the risk of heart failure.

The FDA suggests that patients should contact their health care professional if they experience any symptoms of heart failure, such as shortness of breath, swelling of the feet, ankles, legs, or abdomen, fatigue and weakness, rapid or irregular heart beat, chest pain, or persistent cough or wheezing with white or pink blood-tinged phlegm.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm325508.htm

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