March 29, 2007
Drugmakers voluntarily withdraw pergolide products
Manufacturers of the Parkinson’s drug pergolide have decided to voluntarily withdraw their products from the US market because of potential damage to patients' heart valves.
The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals and two generic pergolide versions manufactured by Par Pharmaceutical and Teva Pharmaceutical Industries.
Pergolide is in a class of drugs called dopamine agonists and is used with levodopa and carbidopa medications to manage tremors and slowness of movement in Parkinson’s disease patients.
In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the US.
Permax was first approved in 1988 for Eli Lilly as an adjunctive therapy with levodopa in Parkinson’s disease patients.
In 2003, the FDA asked for valvulopathy (abnormality of cardiac valves) to be added to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was issued by Lilly.
In 2006, the warning was upgraded to a “black box” status, due to new data concerning risks of heart valve damage.
Two recent New England Journal of Medicine studies confirmed previous findings associating pergolide with increased chance of regurgitation (backflow of blood) of the mitral, tricuspid and aortic valves of the heart, the FDA said.
The agency said its is working with pergolide manufacturers to see if it remains possible to make the drug available under an Investigational New Drug Application for those few patients receiving pergolide and who cannot be successfully converted to other available treatments.