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The U.S. Food and Drug Administration announced new guidelines for testing drug-coated stents. This comes after two years and is in response to safety concerns towards the use of the devices. It will be recommended that large, analytic studies be done before and after these stents are submitted to the FDA. The FDA says that these companies should be tracking patients for up to five years in order to monitor blood clots, heart attacks and any other fatal occurrence. The cost, however, would be in the millions.

Stents are used to hold open arteries after these arteries have been cleared of fatty plaque. Drug coating began to be used in 2003 and is used to prevent scar tissue from growing over the tiny mesh wires called stents.

Soon as the effects of the drug coating came into the light, i.e. higher risks of blood clots, sales plummeted over 1 billion dollars.

In 2006 a series of studies should that even after months of implanting the stent, the coating can increase the risk of blood clots unless the patient continued to use anti-clotting medications.

The proposed guidelines from the FDA are just that, recommendations are not legally binding and could pose a risk for the 650 000 patients who are using drug-coated stents. Stents made by companies such as Boston Scientific Corp.'s Taxus, Medtronic Inc.'s Endeavor and Johnson & Johnson's Cypher have been cleared by the FDA.

[Source: YahooNews]