Medication Adverse Event Alert
March 29, 2007
| ISSUE: | FDA announces withdraw of pergolide due to potential for heart valve damage |
| MEDICATION: | Permax® (pergolide) or as generic form |
The following was excerpted from the FDA Med Watch alert website dated March 29, 2007:
FDA notified healthcare professionals and patients that companies that manufacture and distribute pergolide have agreed to withdraw the drug from the market. Pergolide is a dopamine agonist (DA) used with levodopa and carbidopa to manage the signs and symptoms of Parkinson's disease. Results of two new studies showed that some patients with Parkinson's disease treated with pergolide had serious damage to their heart valves when compared to patients who did not receive the drug. These two studies confirm earlier studies that also describe this problem. Patients currently taking pergolide should contact their healthcare professional about alternate treatments and not abruptly stop taking their medication. Healthcare professionals should assess their patient's need for DA therapy. If continued treatment with a DA is needed, another DA should be substituted for pergolide.
Patients with Parkinson's disease who are taking pergolide should:
Contact their healthcare professional to discuss alternate treatment options.
NOT stop taking Pergolide without consulting their healthcare professional, since stopping pergolide too quickly can be dangerous and several other effective treatments are available.
Healthcare professionals who prescribe pergolide should consider the following:
Assess the patient's need for dopamine agonist (DA) therapy. If continued treatment with a DA is necessary, another DA should be substituted for pergolide. There are other dopamine agonists approved for the treatment of Parkinson's disease that are not associated with heart valve damage. Published transition regimens describe the conversion from one DA to another.
If treatment with a DA is to be discontinued,
pergolide should not be stopped abruptly, because rapid discontinuation of all dopamine agonist therapies can be dangerous. Instead, gradually decrease the dose of pergolide.
Patients who will be taken off pergolide should be told that other effective options for treatment exist, including three other DAs that are not associated with damage to heart valves.
In 2006, a boxed warning regarding the risk of serious heart valve damage was added to the labeling for pergolide. The two recent studies, published in The New England Journal of Medicine in January 2007, confirm earlier studies that also described this problem. In light of this additional safety information and the availability of alternative treatments for Parkinson's disease that do not have comparable safety problems, the companies that manufacture and sell pergolide have stopped shipping pergolide for distribution and will, in cooperation with FDA, work to remove from the market both the name brand Permax (pergolide) and the generic versions of pergolide. The effect of this voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for healthcare professionals and patients to discuss appropriate treatment options and to change treatments. The FDA is working with the manufacturers of pergolide to determine if it is possible to make the drug available to those few patients who are currently taking pergolide where previous efforts to switch to a different treatment have been unsuccessful, or where efforts subsequent to this advisory to switch therapies are also unsuccessful. In the interim, healthcare professionals and patients should consider all treatment options with the understanding that in the future, the drug may no longer be available.
