Drug-eluting stents update: FDA Patient Safety News
In the March 2007 “FDA Patient Safety News Show”, concerns about drug eluting stents were discussed. The FDA show is designed for health professions to provide safety information and news alerts. The portion of the show discussing concerns about drug coated stents was posted on the FDA website today.
In December 2006, an FDA advisory panel was convened to discuss medicated stent concerns which have existed among cardiologists since recent studies indicated the small wire devices are associated with an increased risk of blood clots when compared with older bare metal stents.
>>INFORMATION: Drug eluting stent concerns
The FDA show indicates that the Cypher stent and Taxus stent were approved because they may reduce the rate of re-clogging of the arteries, known as vessel restenosis. However, problems caused by the medicated coating actually increases the risk of potentially fatal blood clots, which many believe is a much greater concern than restenosis.
The increased risk of blood clots in drug eluding stints could continue for several years after the device is placed in the artery. Therefore, the FDA panel emphasized the importance of patients remaining on antiplatelet medications for at least twelve months after the surgery, despite the fact that prior recommendations by the stent makers was for patients to remain on three to six months of anti-clotting therapy.
For many patients who have received the devices, their biggest concern about drug coated stents is why the manufacturers failed to warn of the dangers associated with their product. Had the problems been disclosed, physicians may have recommended alternate treatment such as bypass surgery, medication or bare metal stents.
Now that safety concerns are known, experts are stressing that physicians should only implant the stints for clinically stable patients and in patients who are able to stay on antiplatelet therapy for a long time. Before the safety concerns surrounding drug coated stents were disclosed, the vast majority of all stents implanted were “off-label”, for more complex conditions, which increases the risk of blood clots further. In addition, many patients who received the stents were not properly educated about the importance of continuing long-term antiplatelet therapy, which could reduce the risk of potentially fatal injuries.
DRUG ELUTING STENT LEGAL RIGHTS
Individuals who received a medicated stent and suffered a blood clot, reclogging of the artery or heart attack, may be entitled to financial compensation as a result of the manufacturer’s failure to warn of the stent problems. The drug eluting stent lawyers at Saiontz & Kirk, P.A. represent individuals nationwide who have been injured. To protect your family’s rights, request a free stent lawsuit claim evaluation.