Permax

pergolide mesylate

Permax (pergolide mesylate) is a dopamine agonist, part of a class of drugs that manage the symptoms and signs of Parkinson’s disease, such as tremors and pronounced slowness of movement.

Parkinson’s disease results from a shortage of dopamine in which a person loses the ability to execute controlled movements. Dopamine acts on muscles by reducing contractions, and pergolide drugs work by mimicking the action of dopamine.

On March 29, 2007, the United States Food and Drug Administration (FDA) announced the recall of Permax because of the serious risk of heart valve disease in patients. Permax was immediately recalled for new prescriptions in the United States.

However, patients taking Permax or pergolide generics should not stop using these products without consulting their healthcare professional, as discontinuing pergolide too quickly can be dangerous.

In its releases on the recall, the FDA pointed to “important new drug safety information,” particularly two studies published in the January issue of the New England Journal of Medicine (NEJM) which found that patients on Permax or pergolide generics are four to seven times as likely to suffer heart valve damage as patients who take different drugs. Patients on pergolide drugs were at increased risk of regurgitation of either the mitral, tricuspid, and/or aortic valves of the heart.

Heart valve regurgitation defects prevent valves from closing tightly, allowing blood to flow backward, or regurgitate, across the valve. Symptoms of these injuries, known as primary mitral, tricuspid, or aortic regurgitation or insufficiency, include:

• Shortness of breath
• Pulmonary edema (swelling or an accumulation of fluid in the lungs)
• Difficulty breathing (orthopnoea), especially when lying flat
• Fatigue
• Decreased tolerance for exercise
• Heart palpitations

Patients with heart valve insufficiency may develop acute regurgitation and go into cardiogenic shock, cardiac arrest, or sudden cardiac death.

Sources: U.S. Food and Drug Administration, Release #P07-54, Public Health Advisory: Pergolide, March 29, 2007.