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When Johnson & Johnson''s Cypher heart stent was approved in April 2003, there was already a high amount of competition between drug companies in what analysts have estimated to be a $3 billion market in the U.S. by the end of 2004. Johnson & Johnson was the first company to get approval for the new drug-coated stent and has recently just resolved a long-standing patent dispute by joining forces with competitor Guidant. The union between Johnson & Johnson and Guidant intends to devote about 500 people to just marketing the heart stent device.
It has been no secret that the new drug coated heart stent was seen as a money making battle between drug companies, but for patients that had received implantations of the Cypher stent, heart stent problems were being reported. Recipients of the device began to worry about if they would also experience heart stent problems. After Cypher stents began to sell in April 2003, the FDA warned a few months later in July that it had already received 34 reports of blood clots occurring in Cypher recipients, including 5 deaths.
The heart stent problems continued to be reported, and in October 2003, the FDA issued a second warning. By then, the agency had received over 290 reports of blood clots in Cypher recipients and the heart stent problems were associated with the patient''s death in 60 of the cases. In addition, there were heart stent problems reported in more than 50 patients for reactions such as pain, hives, fever, breathing problems, and blood pressure problems.
Since it is estimated that just a small fraction of actual side effects are ever reported to the FDA, the number of heart stent problems the drug agency received could be only a small understanding of adverse effects. At the time of the second heart stent problems warning, around 260,000 of the Cypher stent had already been distributed to U.S. hospitals and 180,000 delivered abroad. The Cypher stent works by propping open the cleaned out artery and emits a drug to help reduce the risk of the artery becoming clogged again.
In the U.S. and in Europe, coronary artery diseases are the leading cause of death in both men and women. The arrival of drug-coated stents on the market has been seen as a huge new market, and with competing drug companies pouring in resources to promote its own version of the drug coated stent, heart stent problems can occur if patient safety is not kept at the forefront.
Over 2,000 patients every year are suffering avoidable injury and death as a result of stents, small metal devices used to hold open heart arteries, according to two doctors who wrote an editorial published in a leading medical journal.
The ar...
Despite reports of more injuries related to Boston Scientific Corp.’s heart stents, the FDA said they did not plan on taking any further action against the company. Last year, Boston Scientific recalled more than 99,000 Taxus heart stents following re...
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