Pergolide: Voluntary Withdrawal of Products
By Anonymous
United States of America – The Food and Drug Administration (FDA) has announced that manufacturers of pergolide drug products, used to treat Parkinson disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients’ heart valves. The products being with- drawn are Permax(R), the trade name for pergolide, and two generic versions Two new studies showed that patients with Parkinson 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 dopamine agonist used with levodopa and carbidopa to manage the signs and symptoms of Parkinson disease.
Healthcare professionals who prescribe pergolide should consider the following:
* If continued treatment is necessary, another dopamine agonist should be substituted for pergolide. There are other dopamine agonists approved for the treatment of Parkinson disease that are not associated with heart valve damage. Published transition regimens describe the conversion from one DA to another.
* If treatment with a dopamine agonist 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 dopamine agonists that are not associated with damage to heart valves.
One of the drugs included in the recent studies showing increased chance of heart valve problems is cabergoline (Dostinex(R)), another dopamine agonist. This drug is approved in the US for the treatment of hyperproteinaemia disorders, Dostinex(R) is not approved in the US for the treatment of Parkinson disease, For hyperproteinaemia disorders, a considerably lower dose of Dostinex(R) is used.
Reference: PDA News, P07-54 and Public Health Advisory 29 March 2007 at http:// www.fda.gov
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