Withdraw pergolide from the market

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Withdraw pergolide from the market

Warning Date
2007-04-03
Warning Reason
Correction Actions
Advices to Consumer

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 described this problem. Patients currently taking pergolide should contact their healthcare professional about alternate treatments and not abruptly stop taking their medication. Healthcare professions should assess their patient's need for DA therapy. If continued treatment with a DA is needed, another DA should be substituted for pergolide.

Source: U.S. Food and Drug Administration



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