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Pergolide (Permax) Linked to Heart Valve Damage; Withdrawn from Market

The FDA has issued an advisory that pergolide (marketed as Permax) has been withdrawn from the market due to the potential for heart valve damage. Recent studies showed that patients with Parkinson's disease who were treated with pergolide had an increased risk of serious damage to their heart valves.

The FDA advisory outlines the following new guidelines for physicians who prescribe pergolide:

  • 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 heart valve damage.