Parkinson's Drug Pergolide Withdrawn Over Heart Concerns

The Parkinson's disease drug pergolide has been removed from the market because it has been linked to heart valve damage in patients.

The drug, which goes by the brand name Permax, has had a troubled history. It was voluntarily withdrawn Thursday by its maker, Valeant Pharmaceuticals, at the request of the U.S.Food and Drug Administration.

Two generic versions are manufactured by Par Pharmaceuticals and Teva Pharmaceutical Industries.

"The reason for the withdrawal is because of the high rate of damage to the heart valves in users of pergolide," Dr. Robert Temple, director of the Office of Medical Policy at the FDA's Center for Drug Evaluation and Research, said during a teleconference Thursday afternoon. "The damage causes the valve to become leaky. The drug is called a dopamine agonist and is used as starting therapy for Parkinson's patients."

The drug has been available since 1988, and the first reports of heart valve damage surfaced in 2002, Temple said. In 2003, the drug's label was changed to reflect these problems. In 2006, further studies prompted the FDA to mandate a "black box warning" on the drug's label.

The last straw was the publication of two studies in January in the
New England Journal of Medicine that showed a fivefold increased risk of valve damage from taking the drug. One of the studies also revealed that about 23 percent of people on the drug developed heart valve problems, Temple said. "That what led to our new action," he said.

In addition, reports showed that other dopamine agonists did not cause heart valve problems, Temple noted. "Pergolide has no advantage over any of the other therapies for Parkinson's," he said. "Almost all patients can be converted to another drug. We concluded that this drug really didn't have a place in therapy anymore."

Currently, about 12,000 to 25,000 patients are taking pergolide in the United States, and its use has been declining, Temple said.

Temple said there are some patients who only do well on pergolide. "We hope to make some arrangement for those people so they can get the drug, providing they understand the risk," he said.

"We are telling these patients not to stop the drug abruptly," he added. "If the patients, with their physicians, conclude they need a dopamine agonist, there are ways to switch."

The voluntary withdrawal will not take place immediately. This will allow time for health-care providers and patients to make appropriate treatment decisions, Temple said.

According to the U.S.National Institutes of Health, Parkinson's is a disease of the nervous system. The four main symptoms are tremors, stiffness of the limbs and trunk, slowness of movement, and impaired balance. These symptoms usually begin gradually and worsen with time. As they become more pronounced, patients may have difficulty walking, talking or completing other simple tasks.