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Pergolide voluntarily withdrawn from market
Alternative dopamine agonists are still available.
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The FDA recently announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease and pituitary adenomas, will voluntarily remove these drugs from the market because of the risk for serious damage to heart valves.
The products being withdrawn are Permax, the trade name for pergolide, marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva. Pergolide is a dopamine agonist.
In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Physicians should discuss alternate treatments with their patients. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.
Alternatives available
“The FDA reports that cabergoline (Dostinex, Pfizer) will remain on the market and has a low incidence of heart valve damage. As such, the removal of pergolide will not have a great impact,” Robert F. Gagel, MD, head of the division of internal medicine at the University of Texas M.D. Anderson Cancer Center, said in an interview. “Pergolide was the third choice for treatment of hyperprolactinemia behind cabergoline and bromocriptine (Parlodel, Novartis). There is an occasional patient who will respond to pergolide but not other dopamine agonists.
“It is my understanding that the FDA and the drug maker will work to ensure availability,” Gagel said.
Two recent New England Journal of Medicine studies confirmed previous findings linking pergolide with increased chance of regurgitation of the mitral, tricuspid and aortic valves of the heart.
In light of this additional postmarket safety information, the companies that manufacture and sell pergolide will stop shipping pergolide for distribution and, in cooperation with FDA, will withdraw the products from the market.
Permax was approved in 1988 for Eli Lilly and Company as an adjunctive therapy with levodopa in Parkinson’s disease. Valvular heart disease was first described in association with pergolide in 2002. In 2003, FDA asked Lilly to add valvulopathy to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was sent by Lilly.
In 2006, the warning was upgraded to a black box warning, the FDA’s strongest form of warning, because of new data concerning risks of heart valve damage.
The FDA issued a Public Health Advisory detailing the removal of pergolide products from the market. The advisory, which is available at www.fda.gov/cder/drug/advisory/pergolide.htm includes information and recommended actions for physicians, pharmacists and patients.
The effect of the voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health care providers and patients to discuss appropriate treatment options and time to change treatments.
The FDA is working with the manufacturers of pergolide to determine if it might be possible, once the drug is withdrawn from the market, to make the drug available under an Investigational New Drug Application for those few patients who are currently receiving pergolide and who cannot be successfully converted to other available treatments. – by Leah Lawrence