"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 It was voluntarily withdrawn Thursday by its maker, Valeant Pharmaceuticals, at the request of the U.S. Food and Drug Administration."

""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."

" 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
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