|
|
|
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
|
T03-81 |
Media Inquiries: 301-827-6242 |
The Food and Drug Administration (FDA) today updated and clarified information for physicians about adverse events associated with Cordis Corporation’s Cypher Coronary Stent. FDA posted the new information on its web site as a public health notification to physicians.
FDA emphasized that it considers the Cypher drug-eluting stent a safe and effective product when used according to the labeling, particularly the sections of the labeling that deal with the selection of patients and the appropriate use of medication in patients receiving the Cypher stent. Hundreds of thousands of patients have been successfully treated with the Cypher stent, which FDA approved April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries.
In October, FDA notified physicians about reports of thrombosis (clotting) occurring within 30 days after the device was implanted and about reports of possible hypersensitivity reactions. The agency asked doctors and patients to report any such incidents to the FDA.
To date, based on its review of clinical studies evaluating the product in a wide range of patients, it appears that the rate of thrombosis is within the expected rate for any stent. As of Nov. 21, 75 additional (more than 360 total) cases of thrombosis have been reported, including 10 additional deaths (more than 70 total).
Regarding hypersensitivity reactions, in most cases reported to FDA, hypersensitivity was minor (e.g., skin rashes and itching that cleared up within a few days), but there were some severe reactions (including anaphylaxis). Although some of the reactions reported to FDA to date remain unexplained, many of the reactions are believed to be related to standard drug therapy associated with the procedure. As of Nov. 21, FDA has received an additional 20 reports (more than 70 total) of hypersensitivity, with no additional deaths.
Cordis is currently conducting a 2,000 patient post-approval registry as part of FDA’s conditions for approving the Cypher stent last April. The firm expects to provide FDA with the results in early 2004. Meanwhile, FDA will continue to monitor all reported events for the Cypher stent, as it does with all medical devices. The agency will advise physicians of any new information that may be useful in selecting or treating patients as it becomes available.
One of FDA’s roles in promoting and protecting the public health is to monitor products once they have been approved or cleared for marketing to ensure that products continue to have a positive benefit-to-risk profile for their labeled indication. This is particularly true for a new technology, especially one used in a vital organ such as the heart. The agency does this to understand better how the device is being used in the general medical community and to monitor subsequent adverse events.
After its approval by FDA last April, the Cypher stent was widely used to open clogged arteries in patients undergoing angioplasty. Since then, a small number of hospitals have reported a higher than expected number of thromboses. With FDA’s primary focus on patient safety, the agency closely monitored all adverse events to determine whether these events were widespread and whether there was any pattern that would explain them. On July 7, Cordis provided initial information in a “Dear Colleague” letter. FDA shared additional information with physicians in its October 29 web notification. Today’s notice updates that information. It is available at http://www.fda.gov/cdrh/safety/cypher2.html.
####