Parkinson's Drug Tied to Heart-Valve Damage

Mar 30, 11:47 AM

Current Headlines: By Randolph E. Schmid THE ASSOCIATED PRESS

By Randolph E. Schmid

THE ASSOCIATED PRESS

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and Drug Administration said Thursday that pergolide, sold under the name Permax and also in generic versions, is being withdrawn.

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

At least 14 patients have needed to have heart valves replaced, Temple said, adding that he thinks 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, in The New England Journal of Medicine, indicated high rates of valve leakage in patients taking the drug.

He said patients should consult their doctor, switch to another drug or reduce the amount of pergolide used.

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