Permax

Permax and is sold and manufactured as the generic drug pergolide by Par and Teva Pharmaceutical Industries and marketed by Valeant Pharmaceuticals International under the tradename pergolide as well. Permax is a member of a class of drugs known as dopamine agonists and is used with levodopa and carbidopa to manage the signs and symptoms (tremors and slowness of movement) of Parkinson’s disease.

Why Prescribed

Prior to an FDA recall in March of 2007, the drug was used to treat Parkinson’s disease, a motor system disorder which causes tremors in the hands, arms, legs, jaw, and face as well as impaired balance and coordination.  The drug was also used to control restless leg syndrome.

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FDA Approved Uses

In 1988, Permax® (pergolide) was approved by the FDA to treat Parkinson's disease and restless leg syndrome.  It works by stopping the brain from making and releasing the prolactin hormone from the pituitary.

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Side Effects

Side effects of Permax include nervous system complaints, including dyskinesia, hallucinations, somnolence, insomnia; digestive complaints, including nausea, constipation, diarrhea, dyspepsia; and respiratory system complaints, including rhinitis.  The most serious side effect is heart value damage which resulted in the 2007 FDA recall.

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Warnings and Alerts

In March of 2007, the FDA notified consumers that companies manufacturing and distributing pergolide have agreed to withdraw this drug from the market due to the potential for heart valve damage.  Two new studies showed that patients with Parkinson’s 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.

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Drug Contraindications

Permax should not be taken with metoclopramide or certain medications used for psychosis, anxiety or depression.  Other drugs that are considered unsafe with Permax are cimetidine, sleep medication, certain muscle relaxants, tranquilizers, narcotic pain relievers, anti-seizure drugs, certain antihistamines (e.g., diphenhydramine).

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FAQ's

I am currently taking Permax for Parkinson’s Disease, what should I do?

Immediately contact your doctor to discuss alternate treatment options. Do not discontinue use of Permax until you speak with your doctor as stopping pergolide too quickly can cause other harmful side effects and at least three other effective treatments are available that are not associated with damage to heart valves.

Why is is the FDA recalling Permax?

The FDA is responding to two recent New England Journal of Medicine studies which confirm previous findings tying pergolide to increased chance of regurgitation (backflow of blood) of the mitral, tricuspid, and aortic valves of the heart.

Valve regurgitation is a condition in which valves don't close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.

If I am no longer taking Permax do I still have a legal claim?

Possibly. The recent FDA findings raise serious legal concerns for patients who have taken Permax or the families of former Permax patients who died from heart failure or heart-related conditions during or after use of the drug. If you have taken Permax in the past and have suffered heart valve leakage or other harmful side effects, contact a competent drug litigation attorney as you may have a valid legal claim against the manufacturer of the drug.

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