October 12th, 2006

"Serious Danger from Drug-Coated Stents"

Over 2,000 patients every year are suffering avoidable injury and death as a result of stents, small metal devices used to hold open heart arteries, according to two doctors who wrote an editorial published in a leading medical journal.

The article is the latest in a debate among doctors regarding the potentially fatal risks of blood clots and heart attacks linked to the new generation of stents that are drug coated. The drug-coated devices, manufactured by Boston Scientific and Johnson & Johnson, are designed to decrease inflammation and prevent a recurrence of arterial blockage that initially led to the stent insertion.

Concerns About Newer Stents

Currently, stents are the preferred method of therapy for more than one million Americans every year. While all of the devices pose the danger of clotting, especially in the first few days and weeks after insertion, the drug-coated stents have been the main cause for concern.

Serious, life-threatening blood clots in patients using the drug-coated devices months or even years after the stents are inserted have been reported.

Research Findings

According to Dr. Sanjay Kaul, one of the editorial''s authors, the use of drug-coated stents may increase the risk of developing blood clots by 0.6 percent every year compared with those who got the uncoated metal version.

Alarmingly, about 80 percent of patients are receiving the drug-coated devices, which accounts for at least 2,160 additional deaths annually, the doctors calculated. This data assumed that about 45 percent of patients who suffered clots died.

“It''s eerily reminiscent of Vioxx,” said Dr. Kaul, referring to Merck''s popular painkiller that was recalled in 2004 after the drug was linked to heart attacks and strokes. “Initially we didn''t see the signal because the incidence is so rare.”

While stents are the proper treatment for many patients, doctors worry the drug-coated versions are being used way too frequently. They advise patients to ask for bare metal stents or other forms of safer drug therapy.

The U.S. Food and Drug Administration will hold an expert panel meeting in December to evaluate the data and determine whether label changes on drug-coated stents are necessary.

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