Drug Topics - October 22, 2007 - (Page H6)

6HSE DRUG TOPICS OCTOBER 22, 2007 www.drugtopics.com Clinical Practice FDA panels fail to set target levels for renal patients’ hemoglobin Kathryn Foxhall dvisory committees to the Food & Drug Administration recently declined to recommend any set target or range for hemoglobin levels of patients taking erythropoiesis-stimulating agents (ESAs) to combat anemia associated with chronic renal failure. Two randomized clinical trials found that patients for whom clinicians targeted hemoglobin levels of 13 gm/dl were at higher risk of cardiovascular problems, including death. Current labels Many on the recommend adjustment of ESA dosages to get the lowest hemoglobin committees “did level sufficient to avoid the need for not feel comfortable red blood cell transfusion and not to with a single number, exceed 12 gm/dl. The FDA had asked the commitand clinicians tees if ESA labels should be changed in general do not like to state that the target hemoglobin should not be more than approxia single number.” mately 11 gm/dl for patients on hemodialysis. That was the level associRafel Dwaine Rieves, M.D. ated with better survival in the “Normal Hematocrit” study done in the 1990s. The agency also asked whether 11 gm/dl should be the target for chronic renal failure patients not on dialysis, because in the CHOIR (Correction of hemoglobin and outcomes in renal insufficiency) study, which ended in 2005, that level was associated with fewer adverse cardiovascular events. The FDA had also asked the committees to suggest another target level if they did not choose to recommend the 11 gm/dl level for one or both of those populations. But because of a lack of consensus and lack of time to edit the statements at the end of a day with extensive testimony, the committees did not do that. A Big bucks involved With millions of dollars in ESA reimbursements at issue, the joint meeting of the Cardiovascular & Renal Drugs and the Drug Safety & Risk Management Advisory Committees was held recently, with more than 200 people in attendance. According to the Government Accountability Office, the ESA epoetin alfa (Epogen, Amgen; Procrit, Ortho Biotech) accounted for $2 billion in Medicare payments in 2005 and is the highest Part B expenditure drug. Rafel Dwaine Rieves, M.D., acting director, FDA Division of Medical Imaging & Hematology Products, noted there had been a range of opinion on the committees. Some thought the level should be 11; others thought 11 to 12, or another variation. He said it was plain that many on the committees “did not feel comfortable with a single number, and clinicians in general do not like a single number. They like a range.” He said he thought FDA decision-makers would take that to heart. John Jenkins, M.D., director of the Office of New Drugs in FDA’s Center for Drug Evaluation & Research, said FDA officials hope to decide on the labeling changes for both the oncology and the renal indications for ESAs within “weeks, not months.” Quality of life FDA officials also believe they will be able to make statements on quality-of-life issues. Several physicians and patients argue that the higher hemoglobin levels allow many patients to lead a normal life. Rieves said he heard a consensus in the discussion on the importance of identifying and managing ESA hyporesponders, for both current practice and future study. Analyses of both random control trials suggested that patients with the lowest hemoglobin response to an ESA dose are most at risk of serious cardiovascular events. Jenkins cautioned, however, that “for labeling claims, we require substantial evidence, which is very different from clinical practice observations that patients may appear to have felt better in response to therapy…. It’s not as if we are throwing out and disregarding the issue of quality of life.” THE AUTHOR is a writer based in the Washington, Two FDA advisory committees mull the fate of ESAs D.C., area. Photo: Kathryn Foxhall http://www.drugtopics.com

Table of Contents Feed for the Digital Edition of Drug Topics - October 22, 2007

Drug Topics - October 22, 2007 Contents Latebreakers Legislative Victory Builds Momentum for Pharmacy Month Letters Health-System Edition R.Ph.s Brace for Payment Denial for Hospital-Acquired Conditions Topical Human Thrombin Helps Arrest Bleeding FDA Panels Fail to Set Target Levels for Renal Patients’ Hemoglobin Warning Letters Raise Patient Safety Concerns for Fentora Ending/Reversing Weight Gain Man Given Fatal Drug Overdose at Staten Island Hospital Pharmacists Playing More Important Role in Dialysis Treatment AHA President R.Ph.'s Here's How You Can Increase Your Value Premier Launches Comprehensive Quality Improvement Project FDA Approves Dexrazoxane for Treatment of Extravasation New Federal, State Reforms to Ease Disaster Relief Kinks 150 Years of American Pharmacy Ten Tips for MTM Success Independent Superstars: The Ones to Watch The New Dynamic Duo A Parkinson's Disease Primer Classified New Products Advertisers Index Viewpoint

Drug Topics - October 22, 2007

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