Some studies have shown that the prescription medication Mirapex (pramipexole) might increase the risk of heart failure, the FDA said in a Sept. 19, 2012, Safety Announcement. However, shortcomings of the studies prevented the FDA from declaring for certain if the drug does increase the risk of heart failure.
Mirapex is prescribed for the treatment of the signs and symptoms of Parkinson’s disease and for moderate to severe symptoms of primary restless leg syndrome. The medication is in a class of drugs called dopamine agonists. It acts by replacing dopamine in the brain which, in Parkinson’s patients, continues to decrease over time. The brain makes dopamine to control movement.
One study the FDA considered was a group of analyses of randomized clinical trials. The data showed that heart failure in the Mirapex patients occurred more often than in patients taking a placebo. The results of the studies however were not statistically significant.
In another FDA review, the agency considered two epidemiologic studies that seemed to show an increased risk of heart failure in certain circumstances. Results of one of these two studies indicated there was an increased risk of heart failure in new users of the drug within the first three months of their treatment and also in patients 80 years old and older.
In patients who had used Mirapex longer than three months, there was no statistically significant increased risk of heart failure. Both of these studies, however, had a number of limitations, the FDA announcement said.
The FDA said it is working with the drug manufacturer to shed more light on the risk of heart failure in patients taking Mirapex.
In its recommendations, the FDA said physicians and patients should continue to use Mirapex as before. Patients should speak to their doctors of they have any of the signs of heart failure. These include:
- Shortness of breath whether exercising or at rest
- Swelling of the feet, ankles, legs, or abdomen
- Fatigue and weakness
- Rapid or irregular heartbeat
- Chest pain
- Persistent cough or wheezing with white or pink blood-tinged phlegm
Source: FDA
If you or a loved one is diagnosed with heart failure and you believe it was caused by a prescription medication you are taking, you may have a legal claim. To learn more contact the defective drug lawyers at Flood Law Group.