Mirapex (pramipexole) is a medication used to treat Parkinson’s disease and Restless Legs Syndrome. Unfortunately, the U.S. Food and Drug Administration (FDA) has linked Mirapex to a possible increased risk of heart failure. An independent investigation also suggests that Boehringer Ingelheim failed to disclose this risk information. Heart failure is a severe, life-threatening condition that occurs when the heart is unable to supply enough blood to the body.
What is Mirapex?
Mirapex (pramipexole) is an oral medication that is primarily used to treat Parkinson’s disease, a movement disorder caused by progressive loss of dopamine production in the brain. Mirapex is also often used to treat Restless Legs Syndrome (RLS), an uncomfortable condition in which a person has a strong urge to move their legs, especially while sitting or lying down.
Mirapex belongs to a class of medications called dopamine agonists. It works by replacing dopamine, a chemical produced by the brain that controls movement.
Mirapex is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. There are several generic versions of Mirapex manufactured by Sandoz, Teva Pharmaceuticals, and Zydus Pharmaceuticals. The drugs come in six different strengths. The original type of Mirapex was approved by the FDA in 1997.
Mirapex Heart Failure and Failure to Warn
When Mirapex was approved in 1997, heart failure was listed among the dozens of possible adverse events. Researchers noticed the side effect during clinical trials, but never investigated it further to determine the cause. Since then, other studies have also found a statistically significant increased risk of heart failure.
According to a news report in PharmaLot, Boehringer Ingelheim may have failed to fully disclose data linking Mirapex to a significantly increased risk of heart failure. The report quoted a study that mentioned Boehrinher Ingelheim had been tracking the risk of heart failure without public disclosure.
Heart failure is a life-threatening condition in which the heart is unable to pump blood to the body. It may be chronic or acute, and it may affect the entire heart or only half the heart. Heart failure can occur when the heart does not fill with blood, or is too weak to force blood into the body.
When the heart cannot pump blood effectively, tissues and organs in the body become starved of oxygen. Blood and fluid may also accumulate in other areas of the body, including the lungs, legs, and organs.
Mirapex FDA Warnings
The U.S. Food and Drug Administration (FDA) published a Safety Communication regarding Mirapex heart failure risks on September 19, 2012.
The FDA is notifying healthcare professionals about the risk of heart failure associated with Mirapex, after several recent studies found a potential increased risk. An FDA analysis of pooled data from clinical trials also found that heart failure was more frequent with Mirapex than with a placebo, however, the results were not statistically significant. The FDA reviewed two studies that linked Mirapex to a statistically significant increased risk of heart failure, but determined that study limitations make the data difficult to interpret.
The FDA is currently working with the manufacturer to better understand the risk of heart failure associated with Mirapex.
Mirapex Side Effects
Some of the most severe Mirapex side effects may include:
- Heart failure
- Gambling addiction
- Abnormal thoughts or dreams
- Shortness of breath
- Chest pain
- Muscle weakness
- Difficulty remembering or thinking
- Loss of appetite; weight loss
- Decreased sexual interest
- And more