The U.S. Food and Drug Administration (FDA) has warned consumers that a drug used to treat Parkinson’s disease, pramipexole dihydrochloride, which is sold as Mirapex, might cause heart failure.
What Is Mirapex and What Is It Prescribed For?
Mirapex is the brand name for the drug pramipexole dihydrochloride, which is manufactured by the German pharmaceutical company Boehringer Ingelheim AG. The FDA approved Mirapex in 1997 to treat symptoms of Parkinson’s disease and moderate-to-severe restless leg syndrome.
Medical science cannot explain how Mirapex eases symptoms of Parkinson’s disease and restless leg syndrome. Scientists suspect that it stimulates dopamine receptors in a part of the inner forebrain called the “striatum.” Dopamine is a neurotransmitter responsible for the pleasure and reward system of the brain, and it malfunctions in people with Parkinson’s disease and restless leg syndrome, causing involuntary muscular reflexes.
A popular drug, Pramipexole brought in $273.8 million for manufacturers of the generic version in 2010.
Mirapex Might Cause Heart Failure Side Effects
On September 19, 2012, the FDA issued a drug safety communication informing the public that analyses of randomized clinical trials of Mirapex showed that people taking the drug were more likely to suffer heart failure than people who took the placebo.
In its 2012 drug safety communication, the FDA stated that the number of patients who suffered heart failure during Mirapex clinical trials was not statistically significant, and that the FDA would continue researching the connection. Two epidemiological studies, on the other hand, found a statistically significant correlation: Mirapex users were 1.86 times more likely to suffer heart failure than participants who took the placebo, and 1.61 times more likely than people who took levodopa, another medicine used to treat Parkinson’s disease. The risk was more pronounced in older patients and patients who had been taking Mirapex for three months or less. In the face of these results, the FDA again hesitated to declare a clear connection exists, stating that it’s not clear whether the excess cases of heart failure were caused by Mirapex or were influenced by other factors.
Symptoms of heart failure include:
- Rapid or irregular heartbeat
- Chest pain
- Persistent coughing or wheezing with white or pink blood-tinged phlegm
- Shortness of breath (while exercising or at rest)
- Swelling of the feet, ankles, legs, or abdomen
RLG’s Mirapex Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Mirapex lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Mirapex lawsuit on your behalf if necessary.
If you have taken Mirapex and believe it harmed you, contact RLG today.