Officials from the Food and Drug Administration said they asked the marketer of the drug, sold under the brand name Permax, to voluntarily stop sales because of new reports that it can damage heart valves and cause them to leak.
They said the marketer, Valeant Pharmaceuticals International, had agreed to discontinue wholesale distribution.
Permax is in a class of drugs designed to stimulate the brain's production of the neurotransmitter dopamine. It is usually given in combination with other drugs, such as levodopoa.
The agency began warning doctors in 2003 of the possibility for valve damage known as tricuspid regurgitation. New warnings were added last year leading to a "boxed" warning that restricts promotion of the drug.
Two recent reports suggested that the drug raises the risk of valve damage by as much as five times.
Robert Temple, director of FDA's office of medical policy, said the safety concerns, combined with waning use of the drug, caused officials to urge a recall.
"We concluded that it really didn't have a place in therapy anymore," Temple said during a telephone conference call with reporters.
Temple estimated that between 12,000 and 25,000 U.S. patients currently use Permax, known generically as pergolide.
He said patients should not stop taking Permax abruptly but instead should taper off of it with the help of a physician.
"A gradual reduction in dose is the way that should be done," Temple said. The agency said it urged the company to stop wholesale distribution but not pharmacy sales so that patients can continue to use the drug until they switch to different therapy.
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