Dostinex (Cabergoline) and Parkinson’s Disease

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It has been estimated that Parkinson’s disease affects close to 1.5 million people in the United States and over 6 million people worldwide, with around 50,000 new cases diagnosed every year. Parkinson’s disease is considered a progressive neurological disorder characterized by the degeneration of the neurons in the portion of the brain that specializes in movement control. The destruction of neurons creates a shortage of chemical dopamine in the brain, which causes the poor motor control and tremors associated with Parkinson’s disease.

Dostinex, known generically as Cabergoline, is prescription drug sometimes used in the treatment of Parkinson’s disease symptoms, specifically the spasms, stiffness, tremors, and poor muscle control that characterize the disease. The drug is classified as a dopamine receptor agonist and affects the body in some of the same ways as dopamine. Dostinex is manufactured by one of the largest pharmaceutical companies in the world, Pfizer Inc., and was approved in 1996 by the US Food and Drug Administration (FDA) for use in the treatment of the hormonal disorder, hyperprolactinemia. Although Dostinex and Cabergoline are authorized for Parkinson’s disease treatment in other countries, it has not been approved for treating Parkinson’s disease in the United States. In 2005, sales of Dostinex in the United States netted close to $88 million dollars and around 87,000 prescriptions for the medication were distributed.

There are a number of side effects associated with the use of Dostinex, with the most common being nausea (30% experienced), vertigo (27%), somnolence (18%), depression (13%), and dry mouth (10%). Patients also reported incidences of gastric irritation, palpitations, hallucinations, and angina pectoris. 79% of the people taking Dostinex in the clinical trial reportedly experienced at least one side effect and 15% chose to discontinue the study due to the severity of the side effects experienced. Dostinex has also been linked to various types of heart disease, with the most common and severe being valvular heart disease.

Two studies reporting on the association between Dostinex and heart valve disease were published in January 2007 in The New England Journal of Medicine. The clinical studies were conducted by German and Italian physicians. Doctors conducting the Italian study discovered that close to one-fourth of the patients taking Dostinex developed moderate to severe heart valve damage, and the study by German researchers found that patients taking Dostinex were 5-7 times more likely to have leaky heart valves than individuals on other Parkinson’s medications. The statistics indicate a high risk for a severe complication. The damage to the heart valves cannot be reversed by medication and some of the patients who experienced this type of side effect required surgery to repair or replace the damaged heart valves.

To date, a recall of Dostinex or Cabergoline has not been issued by the FDA because neither medication is approved for use in Parkinson’s disease treatment in the United States. The approved use for the treatment of hyperprolactinemia requires a much lower dosage, up to 40 times lower, than the dosage required for the treatment of Parkinson’s disease. Studies indicate that the lower dosage is well below the amount required to adversely affect the heart valves, so a recall is unnecessary. However, patients who have consumed the higher dosage of Dostinex or Cabergoline during Parkinson’s disease treatment are still at an increased risk for adverse cardiovascular events and should seek emergency healthcare immediately if any adverse effects are experienced.

Do I have a Dostinex 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 Dostinex and Cabergoline lawsuits. We are handling individual litigation nationwide and currently accepting new Dostinex cases in all 50 states.

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