Similar to that of the naturally occurring chemical dopamine, Mirapex (generic: pramipexole) tablets are indicated to assist in the treatment of symptoms associated with Parkinson’s disease and restless leg syndrome (RLS). Of significant concern, however, are recent reports that suggest the possibility of a casual relationship between Mirapex treatment and the development of serious complications. As a result, the U.S. Food and Drug Administration (FDA) has informed the public about a possible increased risk of heart failure with Mirapex use.

If you or a loved one has been injured by Mirapex, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.

Mirapex Lawsuit Overview

As a product of Boehringer Ingelheim, Mirapex was approved by the FDA on July 1, 1997 to assist in the treatment of symptoms associated with early and advanced Parkinson’s disease. However, Mirapex may also be prescribed to those diagnosed with restless leg syndrome, a condition in which discomfort in the legs causes a strong urge to move them.

Pramipexole, the active pharmaceutical ingredient found in Mirapex, is in a class of medications known as dopamine agonists. As such, Mirapex works by acting in place of dopamine, a natural substance in the brain that is needed to control movement. Because Parkinson’s disease causes the progressive loss of dopamine in the brain, the addition of pramipexole serves as a replacement. Therefore, by supplementing the loss of dopamine, Mirapex helps those diagnosed with this condition control its symptoms.

Unfortunately, many recipients of Mirapex treatment may be unaware of the side effects that can ensue. Clinical trials have discovered a possible link between this medication and the development of serious side effects. Results of recent studies suggest a potential risk of heart failure that needs further review of available data. According to an FDA Safety Alert, heart failure was more frequent with Mirapex than with placebo. While these results are not statistically significant, they do however indicate an increased risk of heart failure in those who take Mirapex. Due to the increased association, patients who have taken this drug and experienced serious side effects may file their own Mirapex lawsuit in an attempt to gain compensation for their suffering.

Heart Failure

Heart failure is often a chronic condition, but it can sometimes develop suddenly. Often times it is the result of several simultaneous heart complications. The condition may affect only the right side or only the left side of the heart. These are called right-sided heart failure or left-sided heart failure. More often, both sides of the heart are involved. Heart failure is present when:

  • Your heart muscle cannot pump (eject) the blood out of the heart very well. This is called systolic heart failure.
  • Your heart muscles are stiff and do not fill up with blood easily. This is called diastolic heart failure.

These problems mean the heart is no longer able to pump enough oxygen-rich blood out to the rest of your body. As the heart’s pumping becomes less effective, blood may back up in other areas of the body. Fluid may build up in the lungs, liver, gastrointestinal tract, and the arms and legs. This is called congestive heart failure.

Epidemiologic Mirapex Studies

Upon receiving a number of adverse event reports, the FDA evaluated two epidemiologic studies that suggested a possible increased risk of new onset heart failure with the use of Mirapex. However, officials have acknowledged that study limitations make it difficult to determine whether excess heart failure was related to Mirapex use or other influencing factors.

A pooled analysis of randomized, placebo-controlled, parallel phase 2 and 3 clinical trials of Mirapex, first submitted by the manufacturer to FDA in 2008 and later updated in 2010, found that the incidence of newly diagnosed heart failure was more frequent in patients taking Mirapex than in patients receiving placebo. The following FDA Drug Safety Communication details a study used to determine the safety and efficacy of Mirapex use:

To evaluate a possible association of Mirapex with heart failure, Boehringer Ingelheim sponsored an epidemiologic study using data collected from the United Kingdom General Practice Research Database (GPRD). This was a case-control study in a cohort of users of anti-Parkinsonian drugs, aged 40 to 89 years. Seven hundred and eighty-three heart failure cases were matched to 7,454 controls. The results showed 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. Among the individual dopamine agonists, a statistically significant association with heart failure was found in the use of Mirapex

Do I Have a Mirapex Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Mirapex lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by Mirapex, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.