Withdrawal of Parkinson's Treatment - Pergolide
In March 2007, the FDA announced that manufacturers of pergolide drug products, which are used to treat Parkinson's disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients' heart valves. Symptoms include shortness of breath, fatigue and heart palpitations.
The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva.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 in a class of medications called dopamine agonists and is used with levodopa and carbidopa to manage tremors and slowness of movement associated with Parkinson's disease. In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States.
Patients should not stop taking pergolide, as stopping abruptly can be dangerous. Patients taking pergolide should contact their doctors to discuss alternate treatments.
The effect of the voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will give health care providers and patients time to discuss appropriate treatment options and change treatments. Alternative therapies available for Parkinson's disease include three other dopamine agonists that have not been associated with valvular heart disease.
For more details, see the public health advisory.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: April 17, 2007