Endocrine Insider
April 4, 2007

The Food and Drug Administration (FDA) has announced that the manufacturers of the pergolide product Permax and its generic counterparts will voluntarily withdraw the drugs from the market due to concerns that the drugs may cause serious damage to patients’ heart valves. The withdrawal was prompted by two studies published in the New England Journal of Medicine in January that reported an increased risk of valvular heart disease in patients with Parkinson’s disease treated with pergolide or cabergoline.

Pergolide, a dopamine agonist, is used primarily to treat individuals with Parkinson’s disease, though significantly lower doses are used to treat patients with certain endocrine disorders.

The FDA estimates that 12,000-25,000 patients are currently taking pergolide. The FDA suggests patients discuss alternative treatments with their doctors. Furthermore, the agency stresses that patients should not immediately stop taking pergolide, as suddenly stopping the medication can be dangerous.

The market withdrawal should be gradual, providing ample time for physicians and patients to seek alternative treatments. The FDA will work with manufacturers of pergolide to try and make it available under an Investigational New Drug Application. In addition, the agency asserts that Dostinex (cabergoline) will remain on the market for treatment of hyperprolactinemia.

For more information, visit the FDA’s drug information page at http://www.fda.gov/cder/drug/infopage/pergolide/default.htm.