FDA Public Health Advisory Pergolide (marketed as Permax)Mar 29, 2007 | www.fda.gov
The FDA is notifying you that the companies that manufacture and distribute pergolide have agreed to withdraw this drug from the market due to the potential for heart valve damage. Two new studies showed that patients with Parkinson’s disease who were treated with pergolide had an increased chance of serious damage to their heart valves when compared to patients who did not receive the drug. Pergolide is a member of a class of drugs known as dopamine agonists and is used with levodopa and carbidopa to manage the signs and symptoms (tremors and slowness of movement) of Parkinson’s disease.
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. Pergolide is marketed by Valeant under the trade name Permax and sold and manufactured as the generic drug pergolide by Par and Teva.
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.
One of the drugs that was included in the recent studies showing increased chance of heart valve problems is Dostinex (cabergoline), another dopamine agonist. This drug is approved in the U.S. for the treatment of hyperprolactinemic disorders (conditions in which there are elevated levels of prolactin in the blood). Dostinex is not approved in the U.S. for the treatment of Parkinson’s disease. For hyperprolactinemic disorders, a considerably lower dose of Dostinex is used. At these lower doses of Dostinex, there appears to be little chance of heart problems; therefore, Dostinex will remain on the US market for the treatment of hyperprolactinemic disorders.
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.