RandyW Posted January 26, 2007 Share Posted January 26, 2007 This is posted oin other forums but I want to make sure the most people see this as is possible.. DEb had so many shots of this and I am Devastated to readd and Hear this today after dealing with another drug that caused 2 death in Charlotte NC Last year. Information on Erythropoiesis Stimulating Agents (ESA) (marketed as Procrit, Epogen, and Aranesp) FDA ALERT [11/16/2006] FDA is issuing this alert to advise you of a newly published clinical study showing that patients treated with an erythropoiesis-stimulating agent (ESA) and dosed to a target hemoglobin concentration of 13.5 g/dL are at a significantly increased risk for serious and life threatening cardiovascular complications, as compared to use of the ESA to target a hemoglobin concentration of 11.3 g/dL. The “Correction of Hemoglobin and Outcomes in Renal Insufficiency” (CHOIR) study, published November 16, 2006 in the New England Journal of Medicine, reports the adverse cardiovascular complications as a composite of the occurrence of one of the following events: death, myocardial infarction, hospitalization for congestive heart failure, or stroke. The CHOIR study findings underscore the importance of following the currently approved prescribing information for Procrit, Epogen, and Aranesp, including the dosing recommendation that the target hemoglobin not exceed 12 g/dL This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available. Healthcare Professional Information Healthcare Professional Sheet [PDF] or Prescribing Information Epogen and Procrit label and approval history for Drugs@FDA Aranesp label and approval history for Drugs@FDA Other InformationPublic Health Advisory Report Adverse Events to MedWatch Back to Top Back to Drug Index PDF requires the free Adobe Acrobat ReaderDate created: November 16, 2006 CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDERFDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home PageFDA/Center for Drug Evaluation and ResearchNew from CDER New from CDER Recently Added Pages Recently Added Pages Quick Info Links Quick Info Links Who We Are Who We Are What We Do What We Do What We've Accomplished What We've Accomplished Regulatory Authority Regulatory Authority Feedback from Stakeholders Feedback from Stakeholders Online Training Online Training CDER History CDER History Employment Opportunities Employment Opportunities How to Contact Us How to Contact Us New Prescription Drug Approvals New Prescription Drug Approvals Prescription Drug Information Prescription Drug Information Major Drug Information Pages Major Drug Information Pages Consumer Drug Information Consumer Drug Information Over-the-Counter Drug Information Over-the-Counter Drug Information Drug Safety & Side Effects Drug Safety & Side Effects Drug Preparedness and Bioterrorism Response Drug Preparedness and Bioterrorism Response Clinical Trials Information Clinical Trials Information Public Health Alerts & Warning Letters Public Health Alerts & Warning Letters Reports & Publications Reports & Publications Special Projects & Programs Special Projects & Programs Regulatory & Scientific Guidances Regulatory & Scientific Guidances Specific Regulatory Initiatives Specific Regulatory Initiatives Legislation Legislation Prescription Drug User Fee Act Prescription Drug User Fee Act Submitting New Drug Applications Submitting New Drug Applications International Activities International Activities CDER Policies & Procedures CDER Policies & Procedures Compliance Activities Compliance Activities Freedom of Information Act Freedom of Information Act Useful Resources Useful Resources Advisory Committee Meetings Advisory Committee Meetings Meetings, Conferences & Workshops Meetings, Conferences & Workshops CDER Newsletter CDER Newsletter Consumer & Patient Information Consumer & Patient Information Freedom of Information Act Freedom of Information Act International Activities International Activities Pediatrics Initiatives Pediatrics Initiatives Small Business Assistance Small Business Assistance Spanish-Speaking Spanish-Speaking Drug Information Approved Prior to 1998 Drug Information Approved Prior to 1998 Superseded Guidances Superseded Guidances Archival Reports & Publications Archival Reports & Publications Maybe instead Of suing the Tobacco companies for Giving People Lung Cancer, We should think about the Companies Trying to save us from the ones trying to kill us with ther products. WHERE DOES THIS END?????????????????????????? Quote Link to comment Share on other sites More sharing options...
Join the conversation
You can post now and register later. If you have an account, sign in now to post with your account.