FDA requests withdrawal of PD drug pergolide on the back of heart valve risks

The US Food and Drug Administration says that manufacturers of pergolide drug products, which are used to treat Parkinson's disease, will voluntarily remove them from the market because of the risk of serious damage to patients' heart valves. The withdrawals include US drugmaker Valeant's Permax (pergolide mesylate) and two generic versions of the drug, manufactured by US firm Par and Israeli drug major Teva.

Pergolide belongs to the dopamine agonist drug class and is used with levodopa and carbidopa to manage the tremors and slowness of movement of PD. In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the USA, according to the FDA, which advises people on the drug to contact their doctors and discuss alternative treatments. In a press statement, the agency warns that patients should not stop taking the medication, as halting pergolide abruptly can be dangerous.

There are alternative therapies available for PD, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of these available alternatives.