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T03-71 |
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The Food and Drug Administration (FDA) today informed physicians about adverse events associated with Cordis Corporation’s Cypher Coronary Stent. FDA posted the information on its web site as a public health notification to physicians.
FDA has received more than 290 reports of thrombosis (clotting) occurring one to 30 days after the procedure to implant the device. In more than 60 of these reports, use of the device was associated with the death of the patient; in the remainder, the device was associated with injury requiring medical or surgical intervention.
FDA has also received more than 50 reports, including some deaths, that Cordis considers to be possible hypersensitivity reactions. The symptoms include: pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes.
Hundreds of thousands of patients have been successfully treated with the Cypher stent. FDA does not have enough information to determine whether the incidents of thrombosis and hypersensitivity reaction with the Cypher stent differs from those experienced with bare metal stents.
FDA approved the Cypher stent in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. The stent, a cylindrical metal mesh, is designed to keep the arteries from re-clogging after the procedure. It is coated with a thin polymer containing the drug sirolimus that is slowly released into the patient and is intended to reduce the rate of re-blockage that occurs with other stents.
The cause of these adverse events has not yet been determined. FDA and Cordis are working quickly to gather as much information as possible about the circumstances surrounding these events. FDA is also working with the regulatory bodies of other countries to get more information about foreign experience with the Cypher stent.
Until FDA gets to the root of the problems, the agency is encouraging doctors to follow the instructions for use of the stent, and urging them to be vigilant for any patient symptom that may be attributed to hypersensitivity.
Patients who have received this stent should continue to follow their regularly scheduled plan for follow-up appointments with their doctor.
As a condition of approval, FDA is requiring Cordis to conduct a 2000-patient post-approval study and continue evaluating patients from ongoing clinical trials to assess the long-term safety and effectiveness of the stent and to look for rare adverse events that may result from use of the product.
Doctors and patients who have experienced an adverse event related to the stent are encouraged to report the incident to the FDA. Reports may be made one of four ways: online at http://www.accessdata.fda.gov/scripts/medwatch/; by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; or by mail to MedWatch, FDA, HF-2, 5600 Fishers Lane, Rockville, Md. 20857.
The notification to physicians is available at http://www.fda.gov/cdrh/safety/cypher.html.
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