Thursday, March 29, 2007

Parkinson's Drug Pulled From Market

Parkinson's Drug Pulled From Market

AP Science Writer
Published March 29, 2007, 1:45 PM CDT

WASHINGTON -- A drug used by several thousand patients with Parkinson's disease is being pulled from the market because of reports of heart valve damage.

The Food and Drug Administration said Thursday that pergolide, sold under the name Permax and also in generic versions, is being withdrawn at the agency's request.

There are other drugs in the same class that can be substituted, Dr. Robert Temple of the FDA's office of drug evaluation said at a briefing.

At least 14 patients have needed to have heart valves replaced, Temple said, adding he believes that is an underestimate.

He estimated that between 12,000 and 25,000 people currently used the drug, which is known as a dopamine agonist.

"Our conclusion is that pergolide has no demonstrated advantage over other therapies," Temple said. "We believe almost all patients can be converted to another drug."

Pergolide came on the market in 1988. Temple said label warnings were added in 2002 after some reports of heart valve problems were received.

In 2006, a boxed warning regarding the risk of serious heart valve damage was added to the labeling for pergolide.

Temple said withdrawal was requested after two recent studies, published in The New England Journal of Medicine, indicated high rates of valve leakage -- up to 20 percent -- in patients taking the drug.

He said patients should not stop using the drug abruptly, however, urging them to consult their doctor and either switch to another drug or to gradually reduce the amount of pergolide used.

Other dopamine agonists used for Parkinson's disease are not associated with heart valve problems, FDA said.

Pergolide is marketed by Valeant under the trade name Permax and sold and manufactured as the generic drug pergolide by Par and Teva.

Temple said a few people may not be able to change to another drug and the agency is making arrangements to have pergolide available for them.

The new studies also found an increase chance of heart valve damage from another dopamine agonist, cabergoline, sold under the name Dostinex, the FDA said.

Dostinex is not approved in the U.S. for the treatment of Parkinson's disease, but is used at lower doses for other disorders, Temple said. At the lower doses there appears to be little chance of heart problems, the agency said.


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