Mirapex, a drug used to treat Parkinson’s disease and restless leg syndrome, has been linked to an increased risk of heart failure. The FDA reviewed the drug’s clinical trials and found that heart failure was more common with Mirapex than with placebo. Other studies found the same results, but the FDA claims that “study limitations” make it difficult to come to a conclusive result on Mirapex.
So despite these studies, the FDA has issued nothing more than this alert, and directs patients to continue taking their medication.
Symptoms of heart failure include:
- shortness of breath
- swelling of the feet, ankles, legs or abdomen
- fatigue and weakness
- rapid or irregular heart beat
- chest pain
- persistent coughing or wheezing with white or pink blood-tinged phlegm
This is not the first problem linked to Mirapex. In 2008, a case was brought alleging that Mirapex caused compulsive behaviors, in that case, gambling. A federal jury awarded the plaintiff $8.2 million as a result. Following this, hundreds of people that had taken the drug and developed their own compulsive behaviors came forward.
Pfizer finally added the possibility of compulsive behaviors to the drug’s label after reports of behavior such as binge eating, gambling, compulsive shopping, and hypersexual behavior surfaced.
The list of bizarre side effects does not end there. There are also warnings against the possibility of falling asleep without warning during the day, and hallucinations. In some studies, up to 16.5% of people taking the medication suffered hallucinations.
Should the FDA be more aggressive about its warnings?