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Written by Kaitlyn Dmyterko
Two blood-thinning drugs, enoxaparin and eptifibatide, commonly administered to dialysis patients undergoing PCI, have been found to increase patients' risk of in-hospital bleeding, a study published Dec. 9 in the Journal of the American Medical Association found. Lead author Thomas T. Tsai, MD, told Cardiovascular Business News that the study reflects a larger problem of medical administration errors in the U.S., and called for better IT tools to warn physicians about contraindicated medications.
The FDA notified healthcare professionals and patients of a change to heparin, effective today, which will include a new reference standard and test method used to determine the potency of the drug and detect impurities that may be present. The change will result in 10 percent reduction in the potency of the heparin marketed in the U.S., according to the agency.
Cardiva Medical has received clearance from the FDA for its Catalyst III, which is a drug-coated vessel closure device.
The FDA has seized 11 lots of heparin from Celsus Laboratories in Cincinnati.
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Bivalirudin (Angiomax; Medicines Company), an anticoagulant used in STEMI patients who undergo PCI, has been approved by the European Commission.
HORIZONS AMI, which studied 3,602 STEMI patients who underwent primary PCI after two years, continued to find a statistically significant superiority for initial treatment with bivalirudin alone compared with heparin plus GPIIb/IIIa inhibitors, and for drug-eluting stents over bare-metal stents. The study was presented during the late-breaking clinical trials at the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco on Sept. 25.
Orlando, Fla.—A new analysis of the HORIZONS-AMI trial found no increased stent thrombosis with drug-eluting stents (DES) compared with bare-metal stents (BMS)—both shortly after PCI and at one year. It also found that adjunct pharmacologic therapy influenced the risk of stent thrombosis, according to research presented Sunday during the i2 Summit at the American College of Cardiology’s 58th annual scientific session.
Baxter Healthcare, a Baxter International company, is facing at least
five personal injury or wrongful death lawsuits over a patient's
reaction to contaminated heparin, and more are sure to follow as the
FDA reports that the number of deaths attributed to the tainted product
have reached 103.
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