Valeant to Pull Parkinson's Drug

On Evidence of Heart Valve Injury

Valeant Pharmaceuticals International will withdraw a drug once widely used for Parkinson's disease, after two recent studies added to evidence linking it to heart-valve damage.

The drug, Permax, or pergolide, is no longer a popular option for the brain disorder, which affects an estimated 1.5 million Americans. The Food and Drug Administration estimated only about 12,000 to 25,000 people now take the drug, which will also no longer be sold in the U.S. by the two generics makers currently marketing it.

The FDA asked the companies to stop marketing the medication, and they complied, said Robert Temple, director of one of the FDA's offices of drug evaluation.

The two studies, published in January in the New England Journal of Medicine, also tied another Parkinson's drug, Pfizer Inc.'s Dostinex, or cabergoline, to heart-valve problems. In the U.S., FDA officials said, cabergoline is sold for a hormone condition, not for Parkinson's, and is recommended at far lower doses than the ones tied to the heart problems. Dr. Temple said the agency was "not particularly worried" about the drug.

In 2006, U.S. sales of Permax were about $2 million and those for the generics about $12 million, according to data from Wolters Kluwer Health. Dostinex sales were $20 million.

A spokesman for Valeant, of Costa Mesa, Calif., said the company hadn't promoted the drug for several years and had planned to discontinue it later this year.

Bryant Haskins, a spokesman for New York-based Pfizer, said: "Pfizer has been in discussions with regulatory authorities about the appropriate labeling of cabergoline, and we are carefully reviewing today's announcement from the FDA regarding the voluntary withdrawal of pergolide."

Eli Lilly & Co., which began marketing pergolide in the U.S. in 1989 and still sells it overseas, said it has no plans to pull it from foreign markets. The drug is "still an important treatment option for Parkinson's disease in Europe and around the globe," a spokesman for the Indianapolis company said. Eli Lilly believes "the risk-benefit profile of pergolide is still favorable" for certain patients when they follow the safety recommendations, he said.

U.S. sales of the two drugs have fallen as newer products have largely replaced them, but they are still prescribed more widely in Europe, largely because they can be less expensive, said Bryan Roth, a University of North Carolina professor who wrote a New England Journal commentary that accompanied the two studies. The heart-valve risk appeared similar with both products and slightly more prevalent for those taking cabergoline, he said.

One of the new studies was based on a United Kingdom database. It found 19% of those taking pergolide or cabergoline suffered heart-valve damage, five to seven times the rate of those who didn't take the medicine. At higher doses, the risk increased even more. The study examined 11,417 subjects given anti-Parkinson's drugs between 1988 and 2005. Thirty-one patients were diagnosed with new heart-valve problems.

In a study in Milan, Italy, researchers tested 155 people taking various Parkinson's drugs. They found 23% who took pergolide ended up with heart-valve damage, as well as almost 29% treated with cabergoline. That compared with 5.6% of patients in a control group.

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