Johnson & Johnson Cypher Stent
Attorneys
FDA Advises Physicians of Adverse Events Associated with Cordis Cypher
Coronary Stents
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.
An Attorney For You is a free consumer service. We are
not a law firm. We help consumers find the best representation for their
legal needs. Our service allows the consumer to review responses by many
law firms. This process introduces competition amongst the law firms and
allows the consumer to find superior legal representation.
Fill out one simple form and get responses from Cypher Stent
attorneys competing for your case. Email up to 10 law
firms in one click; you review the responses in order to choose the right
attorney for you. | 
