Permax (Pergolide) and Parkinson’s Disease

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Experts believe that Parkinson’s disease affects 1.5 million people in the United States and more than 6 million people worldwide, with close to 50,000 new cases recorded annually. Parkinson’s disease is a progressive neurological disorder characterized by the degeneration of neurons in the area of the brain that controls movement. The degeneration of the neurons creates a shortage of the neurotransmitter chemical dopamine in the brain, which causes the impaired movements associated with the disease.

Permax, known generically as Pergolide, is prescription medication used in the treatment of Parkinson’s disease symptoms, specifically the stiffness, spasms, tremors, and poor muscle control associated with the disease. The medication is classified as a dopamine receptor agonist and has some of the same effects as dopamine on the body. Permax is normally used in conjunction with other medications to treat different symptoms of Parkinson’s disease. It has also been used to treat the discomfort and pain of restless leg syndrome suffered by Parkinson’s disease patients. In 2006, around 12,000 people in the US filled a prescription for Permax or Pergolide.

Permax is manufactured by the global pharmaceutical company Eli Lilley and Co. Its generic counterpart, Pergolide, is manufactured by Par Pharmaceuticals and Teva Pharmaceutical Industries. The medication was approved for release by the US Food and Drug Administration (FDA) in 1988. Common side effects associated with the use of Permax include abdominal pain, back pain, headache, nausea, constipation, and anemia. The medication has been found to affect the nervous system of some patients, causing dizziness, hallucinations, nervousness, personality disorders, and insomnia. The drug can impair associative learning and has been linked to an increased risk of certain types of heart disease, including pulmonary fibrosis, pulmonary hypertension, and valvular heart disease.

Researchers discovered the link between valvular heart disease and Permax in 2002. After studying the findings, the FDA decided that a side effect warning was warranted and an alert about the risk of cardiac valvulopathy was added to the label in 2003. Cardiac valvulopathy is a condition in which the heart’s valves become stiff and/or inflamed. In 2006, the warning was upgraded to a black-box alert, the strongest warning used by the FDA.

In January 2007, two studies were released, one from Germany and one from Italy, concerning the dangerous side effects associated with Pergolide and Permax. The study conducted by Italian researchers found that 23% of the patients taking Permax suffered moderate to severe heart valve damage. The German study discovered that patients using Permax were five to seven times more likely to have leaky heart valves than patients on other Parkinson’s drugs. There is no medication to repair these types of injury to the heart and the only option for some patients is the surgical replacement of the heart valves. The numbers obtained by the Italian and German researchers indicated an extremely high risk for a severe side effect, and the FDA came to the conclusion that a Permax and Pergolide recall was warranted. The recall was voluntarily complied with by the manufacturers in March of 2007. Experts estimate that 500,000 people used Permax before the warning about heart valve damage was added to the label in 2003.

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.

Attention Attorneys: We do not publish prior verdict/settlements. If you are an attorney and would like to refer us a case or for us to send you a profile of prior award judgments or average referral fees, please visit the attorney referral section of our website.

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