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Permax FDA Alerts

The FDA Alert(s) below may be specifically about Permax or relate to a group or class of drugs which include Permax (pergolide).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for pergolide

Permax (pergolide) and generic equivalents

Mar 29, 2007

Audience: Neurologists, other healthcare professionals, consumers

[Posted 03/29/2007] 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.

[March 29, 2007 - FDA]

Permax (pergolide mesylate) - Dec 22, 2003

Dec 22, 2003

Audience: Neurological and other healthcare professionals

FDA and Lilly modified the WARNINGS and PRECAUTIONS sections to inform healthcare professionals of the possibility of patients falling asleep while performing daily activities, including operation of motor vehicles, while receiving treatment with Permax, a dopamine agonist, indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson's disease. Many patients who have fallen asleep have perceived no warning of somnolence. Healthcare professionals should be alerted to the potentially serious risks associated with these events and should carefully evaluate their patients for the presence of somnolence.

[December 15, 2003 Letter - Eli Lilly]
[October 2003 Label, highlighted - Eli Lilly]

Permax (pergolide mesylate) - Feb 24, 2003

Feb 24, 2003

Audience: Neurologists and other healthcare professionals

Lilly and FDA revised the WARNINGS section of the prescribing information to inform healthcare professionals of reports of cardiac valvulopathy involving one or more valves in patients receiving Permax therapy.

[February 2003 Letter - Lilly]

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