December 1, 2011 By:Formulary staff
Patients undergoing percutaneous coronary intervention (PCI) have a lower risk of bleeding when bivalirudin is used compared with either unfractionated heparin (UFH) alone or in combination with a glycoprotein IIb/IIIa inhibitor (GPI).
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December 1, 2011 By:Formulary staff
FDA is requiring that manufacturers of tumor necrosis factor (TNF) blockers perform enhanced safety surveillance in children, teenagers, and young adults, the agency said on November 3 in an ongoing safety review of this class of biologic products.
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November 1, 2011 By:Formulary staff
Safety information chagnes to the package insert for bevacizumab were issued by FDA on September 30, 2011.
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November 1, 2011 By:Formulary staff
Two Drug Safety Communications providing updated warnings regarding potentially serious interactions when methylene blue or linezolid are co-administered with certain serotonergic psychiatric medications were released by FDA on October 20, 2011.
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October 1, 2011 By:Formulary staff
FDA is requiring the zoledronic acid (Reclast, Novartis) prescribing information to now include a warning not to use the drug in those with renal dysfunction.
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October 1, 2011 By:Formulary staff
In a safety communication released September 7, 2011, FDA announced it is requiring the prescribing information for all tumor necrosis factor-alpha blockers to include a black-boxed warning regarding an increased risk of infection from 2 bacterial pathogens, Legionella and Listeria.
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October 1, 2011 By:Formulary staff
Biologic agents have no effect on the rate of major adverse cardiovascular events in patients suffering from chronic plaque psoriasis.
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September 1, 2011 By:Formulary staff
Spurred by the results of the Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy trial, FDA informed prescribers about its ongoing review of dronedarone's cardiovascular safety.
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September 1, 2011 By:Formulary staff
FDA released a safety communication regarding its ongoing review of data to evaluate whether bisphosphonates are associated with an increased risk of esophageal cancer.
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