Mirapex (pramipexole) is a drug treatment for Parkinson’s disease and Restless Legs Syndrome, two disorders that cause uncontrollable movement. Unfortunately, there is growing evidence linking Mirapex to heart failure. There is also evidence that Boehringer Ingelheim may have withheld this risk information. In September 2012, the FDA issued a Safety Communication about the life-threatening risk of Mirapex heart failure.
What is Mirapex?
Mirapex (pramipexole) is a medication used primarily to treat two conditions: Parkinson’s disease and Restless Legs Syndrome (RLS). People with these conditions have uncontrollable movement disorders.
Parkinson’s disease occurs when the brain gradually stops producing dopamine, a chemical that controls movement. Mirapex treats Parkinson’s disease by replacing dopamine. It belongs to a class of drugs called dopamine agonists, which mimic the effects of dopamine in the brain.
Mirapex was created by Boehringer Ingelheim Pharmaceuticals, Inc., and was initially approved by the U.S. Food and Drug Administration (FDA) in 1997. It is now available as a generic medication in six different strengths. Generic Mirapex is sold by Sandoz, Teva Pharmaceuticals, and Zydus Pharmaceuticals.
Mirapex Heart Failure and Failure to Warn
When Boehringer Ingelheim conducted the initial clinical studies to approve Mirapex, researchers noticed a risk of heart failure. This risk was included on the initial warning information, along with dozens of other side effects. The drug company never investigated the potential risk further, despite the fact that the initial clinical trials were relatively small.
Subsequent studies also revealed a statistically significant increased risk of heart failure. Then, in May 2012, the news agency PharmaLot uncovered evidence that Boehringer Ingelheim may have failed to fully disclose the risk of heart failure. Specifically, they cited evidence that the drug company was tracking the risk of heart failure without public disclosure.
Heart failure is a severe disorder that occurs when the heart does not supply the body with enough blood. The condition can occur suddenly, or gradually worsen over time and cause death. Blood and fluids often back up in the body, leading to severe swelling in the lungs, legs, and organs. Tissues and organs can also become starved of oxygen due to lack of blood, leading to organ failure.
Mirapex FDA Warnings
On September 19, 2012, the U.S. Food and Drug Administration (FDA) published a Safety Communication to announce they were investigating a potential link between Mirapex and heart failure.
The FDA conducted their investigation in response to several recent studies that found an increased risk of heart failure in Mirapex patients. When researchers conducted a pooled analysis of the clinical trials, they found Mirapex was associated with a higher risk of heart failure than patients taking a placebo — however, they cautioned that these results were not statistically significant. The FDA also reviewed two studies linking Mirapex to a statistically significant increased risk of heart failure, but they decided the studies were limited.
The FDA did not conclusively link Mirapex to heart failure, and the agency will be working with the manufacturer to better understand this potential increased risk.
Mirapex Side Effects
Severe side effects linked to Mirapex may include the following:
- Heart failure
- Gambling addiction
- Strange dreams, abnormal thoughts
- Breathing problems, shortness of breath
- Pain in the chest
- Weak muscles
- Problems thinking or remembering things
- Decreased appetite and weight loss
- Loss of interest in sexual activity
- And more