60 deaths in patients implanted with the device. Federal regulators are linking Johnson & Johnson’s blockbuster Cypher stent to more than 60 deaths in patients implanted with the device, according to an advisory issued yesterday.
For the second time since its approval by regulators in April, doctors were notified about problems associated with the stent, a medicated version of the tiny steel devices used to support arteries after angioplasty surgery.
The Food and Drug Administration’s advisory reported a more than 10-fold increase in the number of cases of acute thrombosis, or blood clotting, in patients who received a Cypher stent. The number could actually be higher because of under reporting, a FDA official said.
But Barry Cohen, a cardiologist at Morristown Memorial Hospital, said the deaths had to be viewed in proper context. “The actual number of patients treated has also gone up dramatically,” he said.
About 450,000 patients worldwide have received Cypher stents
About 450,000 patients worldwide have received Cypher stents. Nearly 260,000 of those patients are in the United States.
“There is no procedure, whether you’re using an old device or a new device, that is without complications,” Cohen said. “If I needed a stent today, that’s what I would ask for (the Cypher stent) for myself or my family.”
Johnson & Johnson is banking on the Cypher stent to live up to blockbuster potential and deliver billions in revenues. With sales slipping on some of its top-selling drugs, the New Brunswick-based health care company, doesn’t have a lot else to count on.
After overcoming initial problems meeting demand for the stent, the company now finds itself trying to get to the root of safety problems with the device.
Johnson & Johnson’s shares fell yesterday to a 52-week low in heavy trading.
Johnson subsidiary that developed the novel coronary device
Three months ago, Cordis, a Johnson & Johnson subsidiary that developed the novel coronary device, issued a similar warning to physicians. The company reported five deaths and nearly 50 instances of serious blood clotting.
In its advisory to doctors, the FDA said it has received more than 290 reports of patients experiencing clotting within a month after receiving a Cypher stent. The FDA also has received more than 50 reports, including some deaths, that may be a result of hypersensitivity reactions, according to the agency’s advisory.
Cordis said the rate of thrombosis, or clotting, remains lower than 1 percent worldwide. “The safety profile is still very positive,” said Martin Schildhouse, a company spokesman.
The stock closed at $49.48, down $1.06, or 2.1 percent.
Analysts were hard-pressed to assess the impact the warnings might have on sales of the Cypher. Girish Tyagi of Thomas Weisel Partners in Boston, said he did not expect a slowdown in the use of the Cypher. “We maintain the clinical utility outweighs the risks,” he said.
Tom Gross, who heads the FDA division responsible for monitoring products after they go to market, said data from clinical studies on the stent were “very reassuring” on the issue of clotting. Clotting occurs at a higher rate in bare metal stents, a precursor to the Cypher.
Are these events in excess of what we might expect
“Are these events in excess of what we might expect, we don’t have any evidence to suggest that,” Gross said.
The FDA relies on the public to provide information on any adverse effects. As a result of the passive nature of the system, Gross said there is an expectation that problems are under-reported.
“In one sense, we’re aware of this potential problem,” he said. “In another sense, we want to find out more. This is what we know about the situation at this point in time.”
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