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Johnson & Johnson Tanks on Stent Warning

The FDA says its drug-eluting stents are associated with more deaths.

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Johnson & Johnson

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are down $1.61, or 3%, to $48.93 after the Food and Drug Administration issued a warning to physicians that the Cypher Coronary Stent from the company's Cordis subsidiary has been associated with 60 deaths and an additional 230 serious adverse clotting events requiring medical or surgical intervention.

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In addition, the FDA said it also received over 50 other adverse event reports, including deaths, due to hypersensitivity reactions.

This is the second time the FDA has issued a letter of concern about the device. After receiving a number of reports of similar clotting events, Cordis, in conjunction with FDA, issued a letter on July 7, 2003, reminding physicians to follow the instructions for use and to report any adverse events to the agency.

The company has yet to release a statement in reaction to the FDA's notice and does not break out results for Cordis, but in its most recent quarterly earnings release, it cited the new stent as a strong contributor to earnings and profits, saying the product was used in 45% of all coronary angioplasty patients in the U.S.

The device has not been pulled from the market. The FDA said that "hundreds of thousands of patients have been successfully treated with the Cypher stent," and that it doesn't have "enough information to determine whether the incidents with the Cypher stent differs from those experienced with bare metal stents."

The FDA emphasized that the cause of the adverse events has not been determined, but they are working with Cordis and foreign regulatory agencies to determine next steps. In lieu of pulling the product, the FDA is requiring Cordis to continue a 2,000-patient clinical study to assess the product's long-term safety and effectiveness. The FDA approved the stent in April 2003 for use in angioplasty procedures to unblock coronary arteries. The stent is unique because of its mesh design and sirolimus lining, a drug designed to reduce the rate of re-blockage that occurs with prior-generation stents.