The U.S. Food and Drug Administration has issued a public health Web notification on reports of subacute thromboses and hypersensitivity reactions with the use of the Cordis Cypher coronary stent.
As of the 20th October, the FDA has received more than 290 reports (more than 260 from within the U.S. and more than 25 outside the U.S.) involving subacute thrombosis associated with the Cypher sirolimus-eluting stent. More than 60 reports of subacute thrombosis were associated with patient death, and the remaining reports were associated with patient injury requiring medical or surgical intervention.
The FDA has also received more than 50 reports, including some deaths, that Cordis considers possible hypersensitivity reactions. The symptoms reported include pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes.
"We do not have sufficient data to establish rates for these events, nor can we determine whether these rates are different from those experienced with bare metal stents," the FDA states in its advisory.
The FDA are working with Cordis to gather as much information as possible about the circumstances surrounding these events and are 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.
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.
Reference
FDA talk paper, 'FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents', 29th October 2003.