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Permax (generically known as peroglide), a drug used in the treatment of Parkinson's disease, has been pulled from United States shelves because it has been associated with an increased risk of heart valve damage.
Food and Drug Administration officials asked the drug makers to stop sales in light of the new reports that claim the drug can cause heart valve damage, which can cause the valves to leak.
Valeant Pharmaceuticals International, the drug's manufacturer, agreed to halt wholesale distribution.
Permax is a member of a class of drugs that stimulate dopamine production. Permax is often administered in conjunction with levodopoa and other drugs.
As early as 2003, the FDA began to warn doctors of the potential for valve damage (tricuspid regurgitation) with the drug. The drug got a warning label change last year with the inclusion of a black box to alert consumers of its dangers.
The Reports
Two recent studies have suggested that Permax increases the risk of valve damage by up to five times.
The director of the FDA's office of medical policy, Robert Temple, said the safety risks coupled with the decreased use of the drug, prompted the recall.
“We concluded that it really didn't have a place in therapy anymore,” said Temple.
Temple estimated the amount of patients currently using Permax or peroglide at between 12,000 and 25,000 in the United States.
Recommendations
Temple recommended that patients who are taking Permax do not stop taking it abruptly. Instead, he said, they should consult a physician to help them get off it gradually.
“A gradual reduction in dose is the way that should be done,” said temple.
The company will stop wholesale distribution, but will continue to supply it to pharmacies so that patients who are on it can continue to use it until they switch over to a different treatment.
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