FDA Asks Manufacturer to Withdraw Permax From the Market

Valeant Pharmaceuticals International Agrees to Voluntarily Withdraw Permax From Market

Permax (pergolide) manufacturer Valeant Pharmaceuticals International has acquiesed to the FDA's request to voluntarily withdraw its Parkinson's drug Permax from the market following reports of heart valve damage in patients taking Permax. In 2003 a Dear Doctor letter was issued to healthcare professionals warning of potential for adverse side effects, including heart valve damage. The drug has carried a black box warning since 2006 about the heart valve problems and use of the product has been steadily declining since then.

Robert Temple, M.D., associate director for medical policy at the Center for Drug Evaluation and Research, said the FDA decided to ask makers of the drug to take it off the market following publication of two new studies, published in the New England Journal of Medicine in January 2007, which confirmed the link between Permax and valve disease. Those studies also reported that "this risk did not extend to other drugs in this class." "I would say there was general agreement that the time for this drug has run out," Dr. Temple said.

Although the companies have agreed to stop shipping pergolide for distribution, a limited supply of the drug will remain available in pharmacies in order to allow time for healthcare professionals and patients to discuss appropriate treatment options.

Dostinex (cabergoline), another dopamine agonist in the same class as Permax, was also linked to valve disease in the NEJM papers. Dostinex is used in Europe for treatment of Parkinson's disease but in the U.S. it is only approved for the treatment of hyperprolactinemic disorders, which requires a much lower dose. At that lower dose, he said, there have been no reports of increased risk of valvulopathy.

Read the FDA MedWatch 2007 Public Health Advisory about Permax.

Read more on our Permax and Dostinex Information Page >>