Permax (Pergolide) and Restless Leg Syndrome

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Permax (generic: Pergolide) is a prescription drug used to treat the physical symptoms of Parkinson’s disease, namely the tremors, poor muscle control, and restless leg syndrome associated with the disease. Restless leg syndrome is characterized by uncomfortable sensations in the lower extremities and is considered a neurological disorder. Experts estimate that restless leg syndrome affects nearly 12 million people in the United States.

Patients diagnosed with restless leg syndrome describe the sensations as creeping, burning, or like insects crawling inside the legs. The feelings can range from irritating to severe, and trying to relax aggravates the symptoms. The sensations are usually stronger at night, causing difficulty in falling asleep and staying asleep. Without treatment, restless leg syndrome can cause exhaustion, daytime fatigue, an inability to concentrate, impaired memory, and difficulty in performing daily tasks. The symptoms of restless leg syndrome can be relieved by moving the affect part of the body, causing some afflicted patients to keep their legs in constant motion to alleviate the sensations.

Permax and its generic counterpart, Pergolide, treat the sensations of restless leg syndrome in Parkinson’s disease patients by mimicking the bodily effects of dopamine, a brain-signaling chemical. A deficiency of dopamine in the brain is a main characteristic of Parkinson’s disease, and is considered the cause of the poor muscle control and tremors that Parkinson’s disease is known for. Permax is manufactured by Eli Lilley and Co., and its generic counterpart, Pergolide, is manufactured by Par Pharmaceuticals and Teva Pharmaceutical Industries. The drug was approved by the US Food and Drug Administration in 1988. In 2006, nearly 12,000 individuals in the United States filled prescriptions for Pergolide or Permax.

The common side effects noted during use of Permax include, back pain, abdominal pain, constipation, headache, nausea, and anemia. In some patients, side effects of the nervous system were observed, such as nervousness, personality disorders, dizziness, insomnia, and hallucinations. The medication has also been linked to a higher risk of some types of heart disease, such as pulmonary hypertension, pulmonary fibrosis, and valvular heart disease.

The link between valvular heart disease and Permax was discovered in 2002, prompting the FDA to issue a side effect warning about the increased risk. The alert warned specifically about the risk of cardiac valvulopathy, a condition where the valves of the heart become stiff and/or inflamed. In 2006, the alert was upgraded to the FDA’s strongest warning, a black-box alert.

Two studies were released in January of 2007 concerning the increased risk of valvular heart disease in patients taking Pergolide and Permax. One found that patients taking Permax were 5-7% more likely to suffer from leaky heart valves, and the other found that 23% of the patients taking Permax developed moderate to severe heart valve damage. These types of injuries cannot be repaired with medications and the only option is surgery to replace the heart valves. These numbers represent a high risk of a very serious side effect, and the FDA decided to issue a Permax recall. Permax and Pergolide manufacturers complied with the recall in March of 2007.

Side Effects of Permax

• heart-valve damage (Aortic and Mitral Valve Injuries)
• Primary Pulmonary Hypertension
• cardiac valvulopathy
• valvular heart disease
• leaky heart valves
• pulmonary fibrosis (retroperitoneal, pleural, and pericardial fibrosis)

Do I have a Permax Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Permax and Pergolide lawsuits. We are handling individual litigation nationwide and currently accepting new Permax cases in all 50 states.

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