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FDA Warns of Heat Failure with Mirapex

Filed September 21st, 2012 Laurie

The U.S. Food and Drug Administration has notified healthcare providers about a possible increased risk of heart failure in patients taking Mirapex (pramipexole).

Mirapex is used to treat restless leg syndrome and Parkinson’s Disease.

The agency’s safety alert stops short of an official warning announcement for the drug. The FDA has not definitively concluded that Mirapex raises the risk of heart failure and more research is needed. They evaluated a pooled analysis of randomized clinical trials and discovered that heart failure was more frequent with Mirapex than with placebo.

The FDA also evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with Mirapex use. The agency, however, could not determine if excess heart failure was related to Mirapex or other influencing factors.

Officials recommend that patients who take Mirapex contact their healthcare provider if they experience any of the following symptoms:

  • Shortness of breath, with exercise or at rest
  • Swelling of the legs, feet, ankles, or abdomen
  • Fatigue and weakness
  • Rapid or irregular heartbeat
  • Chest pain
  • Persistent cough or wheezing with white or pink-tinged phlegm
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