Parkinson's drug Permax withdrawn from market.
The manufacturers of the Parkinson's therapy Permax (pergolide) on March 29 agreed to take the dopamine agonist off the market as soon as possible, according to the Food and Drug Administration, which sought the recall.
The FDA was spurred to take action in light of data published in January in the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. that showed that patients taking Permax had a fivefold higher risk of valvulopathy than did patients taking other dopamine agonists, said Dr. Robert Temple, director of the Office of Drug Evaluation I at the Center for Drug Evaluation and Research The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. CDER reviews New Drug Applications to ensure that the drugs are safe and effective. It is one of five Centers at the United States Food and Drug Administration. , in a telephone briefing with reporters.
Alternative Parkinson's therapies are available to patients, he said.
Permax is usually given in combination with levodopa levodopa: see l-dopa.
Organic compound (L-3,4-dihydroxyphenylalanine) from which the body makes dopamine, a neurotransmitter deficient in persons with parkinsonism. or carbidopa. It was approved in the United States in 1988. Reports of valvulopathy first emerged in 2002. The side effect was added to the label in 2003, and when two new studies in 2006 showed a high rate of regurgitation regurgitation /re·gur·gi·ta·tion/ (re-ger?ji-ta´shun)
1. flow in the opposite direction from normal.
2. vomiting. , the drug received a black box warning, said Dr. Temple.
The latest studies confirmed those reports and that the leaky valve problem seemed to be specific to pergolide, he said. One showed that 23% of patients taking pergolide had valvulopathy, compared with none of those taking non-ergot-derived dopamine agonists and 6% of controls (N. Engl. J. Med. 2007;356:39-46).
The FDA estimates that only 12,000-25,000 Americans take Permax. It is marketed by Valeant Pharmaceuticals International and also is sold as a generic by Par Pharmaceutical Co. and Teva Pharmaceuticals Industries Ltd. Those manufacturers have stopped shipping the drug, but withdrawal from retail will be delayed slightly to allow patients to gradually discontinue use.
The agency is working with the manufacturers to keep pergolide available in special circumstances for the very small minority of patients who cannot be effectively switched to another medication, Dr. Temple said.
BY ALICIA AULT
Associate Editor, Practice Trends