Heart Stents

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Heart Stent Side Effects

With all the excitement of the Cypher stent entering the market, the reports of heart stent side effects were overshadowed. The battling drug companies trying to gain an edge on what is predicted to be an estimated $3 billion market in the U.S. by the end of 2004 may threaten the focus placed on any potential heart stent side effects. Johnson & Johnson has finally settled its dispute against rival Guidant over patent rights by joining forces. Already, the two companies have devoted around 500 people to just the marketing of the stent.

Johnson & Johnson was the first company to receive approval for the new drug coated stent. Called the Cypher stent, the tiny metal scaffold is coated with a drug called Sirolimus to help reduce the chances that the artery will clog again. Since coronary artery diseases are the leading cause of death in the U.S. and in Europe, the new heart stent was immediately popular. Released in April, the FDA received reports of heart stent side effects just a few months after.

In July 2003, three months after sales for the Cypher stent begun, the FDA warned it had already received reports of blood clots in 34 patients, including five deaths. The deadly heart stent side effects were especially troubling when in October the FDA issued its second warning about Cypher stents. The public heart stent side effects warning caused alarm in some Cypher recipients.

Reports of over 290 blood clots had been counted amongst Cypher recipients, with deaths occurring in more than 60 of the cases. There were also allergic-type heart stent side effects received in over 50 reports. Just a small percentage of adverse effects are estimated reported to the FDA, so the actual number of heart stent side effects is probably much higher.

After the FDA issued its second heart stent side effects warning, the maker of Cypher stents, Cordis Corp., said it was conducting a 2,000 patient study to track rare heart stent side effects. Opposed to the traditional bare metal stents, Cypher recipients must take the anti-clotting drugs for three months after getting the stents versus the two weeks with the older stents. Proper stent size and implantation technique is extremely important in reducing risks of suffering heart stent side effects.

In the U.S. and in Europe, coronary artery diseases are the leading cause of death in both men and women. The entrance of the drug-coated stents has been estimated to become a $3 billion market by the end of 2004 in the U.S. There are three kinds of stents being made, and there is a lack of definitive studies showing which device may have less risk of heart stent side effects or which is more effective. Drug companies are expected to continue battling out a lead in the heart stents market.

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