The Food and Drug Administration on Thursday announced a "voluntary withdrawal" of a Parkinson's disease drug sold generically as pergolide and under the brand name Permax.
The agency said the drugs, whose use has been declining, were pulled following reports of heart-valve problems and two recent studies published in the
New England Journal of Medicine.
Pergolide is used with other drugs to help manage symptoms, such as tremors, for Parkinson's, a neurological disorder.
Permax has been sold by
, and generic pergolide has been sold by
"There was general agreement that the time for this drug had run out," said the FDA's Dr. Robert Temple in a telephone press conference. Although the companies are voluntarily withdrawing the drug, Temple said the FDA requested that they do so.
Approved by the FDA in 1988, the drug, originally developed by
, has been the subject of increased warnings about heart-valve damage on its label, including a "black box" -- the agency's toughest warning -- last year.
The FDA said an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies last year. The agency said patients shouldn't abruptly stop taking the drug but should check with their physicians for other treatments. The FDA said three other drugs in the same class as pergolide haven't been linked to heart-valve problems.
"The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available," the agency said.