Cypher Coronary Stent
The FDA warned that Johnson & Johnson's newest heart device, the drug coated Cypher Stent, has been linked to hundreds of cases of blood clots and said the the device has been linked to more than 60 deaths.
The FDA approved the Cypher Stent earlier this year for angioplasty procedures to open clogged coronary arteries. In most cases, a stent is left permanently in the artery to keep the vessel open after angioplasty. The Cypher stent stent is designed to slowly release a drug which helps to reduce the rate of re-blockage that occurs with existing stents.
Each year 800,000 angioplasty procedures are performed in the United States to open clogged coronary arteries. In approximately 15%-30% of patients, the artery becomes clogged again (a condition called restenosis) within a year, and it must be treated again with a procedure such as angioplasty or bypass surgery.
This warning was the second warning sent to doctors since the launch of the Cypher stent in April 2003. The FDA said Johnson & Johnson's drug-coated stent, a tiny wire mesh device used to prop open surgically cleared arteries and deliver medicine to keep them open, resulted in more than 290 cases of blood clots among patients 30 days after receiving the device.
The FDA also said that the defective Cypher stent was associated with other serious injuries that required medical or surgical intervention including more than 50 reports, including some deaths, that J&J considers to be possible hypersensitivity allergic reactions. The symptoms include pain, rash, respiratory alterations, hives, itching, fever and blood pressure changes.
FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents
11/03/03 - 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