Dostinex (Cabergoline) and Restless Leg Syndrome

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Dostinex (generic: Cabergoline) is a prescription medication sometimes used to treat the physical symptoms of Parkinson’s disease, namely the poor muscle control, tremors, and restless leg syndrome associated with the disease. Restless leg syndrome is considered a neurological disorder and is characterized by uncomfortable sensations in the lower extremities. It has been estimated nearly 12 million people in the United States are affected by restless leg syndrome.

Patients suffering from restless leg syndrome describe the feelings as creeping, burning, or like insects crawling inside the legs. The sensations can range from slightly irritating to severe. Trying to relax normally aggravates the symptoms and the sensations are usually more severe in the evening, causing problems with falling asleep and staying asleep. If left untreated, restless leg syndrome can cause daytime fatigue, exhaustion, impaired memory, an inability to concentrate, and difficulty performing normal tasks. The sensations of restless leg syndrome can often be relieved by motion in the affected part of the body, causing some patients to keep their lower extremities in constant motion to alleviate the symptoms.

Dostinex and its generic counterpart, Cabergoline, treat the symptoms of restless leg syndrome by imitating some of the effects of dopamine, a brain-signaling chemical. A deficiency of the chemical dopamine in the brain is thought to be the main cause of Parkinson’s disease, and is the catalyst that causes the poor muscle control and tremors that the disease is known for. Dostinex was created by the pharmaceutical giant, Pfizer, Inc., and received approval from the US Food and Drug Administration in 1996 for use in the treatment of the hormonal disorder, hyperprolactinemia. Although Dostinex and Cabergoline are used for the treatment of Parkinson’s disease in other countries, it has not been approved for use in treating Parkinson’s disease in the United States. Sales of Dostinex in the United States netted close to $88 million dollars in 2005 and close to 87,000 prescriptions for the medication were filled that year.

The most common side effects associated with the use of Dostinex are nausea, vertigo, somnolence, depression, and dry mouth. Patients also reported incidences of hallucinations, gastric irritation, angina pectoris, and palpitations. 79% of patients taking Dostinex during the clinical study reported experiencing at least one side effect and 15% of the patients chose to discontinue treatment due to the severity of the side effects they experienced. The medication has also been associated with a higher risk of some types of cardiovascular disease, such as pulmonary fibrosis, pulmonary hypertension, and valvular heart disease.

Two studies reporting on the link between Dostinex and valvular heart disease were published in January 2007. The clinical studies conducted by German and Italian physicians discovered that around one-fourth of the patients taking Dostinex developed moderate to severe heart valve damage, and patients using Dostinex were 5-7 times more likely to have leaky heart valves than patients on other medications for the treatment of Parkinson’s disease. The results of the study indicated a high risk for severe adverse events. Damage to the valves of the heart cannot be reversed by medication and the patients who experienced this adverse event required surgery to repair or replace the damaged heart valves in some cases.

A recall of Dostinex or Cabergoline has not been issued by the FDA because approved use for the treatment of hyperprolactinemia requires a much lower dosage than the dosage required for the treatment of Parkinson’s disease. The dosage to treat hyperprolactinemia can be as much as 40 times lower than the effective dosage for treating the symptoms of Parkinson’s disease. Studies have indicated that the dosage for hyperprolactinemia is well below the amount required to adversely affect the heart valves, making a recall of the medication unnecessary. However, patients taking the higher dosage of Dostinex or Cabergoline for Parkinson’s disease treatment are still at risk for heart valve damage and should seek emergency healthcare immediately if any adverse side 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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