Healthcare Traveler - November 2008 - (Page 41)

ESAs must have new label warnings T he FDA has required that erythropoiesis stimulating agents (ESAs) darbepoetin alfa (Aranesp) and epoetin alfa (Epogen), used to treat anemia, be labeled with a revised box warning and a new restricted indication. The new labels warn physicians who seek to cure their patients’ cancer with myelosuppressive therapy that they should not also prescribe ESAs. The agency’s order also states the labels must specify that dosing needs to be initiated when hemoglobin levels are less than or equal to 10 g/dL. The order removes the phrasing “except where the patient is unable to tolerate this degree of anemia due to co-morbid conditions” from the instructions about hemoglobin levels. The FDA wrote that the company’s phrasing “suggests that you have been granted an indication for treatment of anemia in patients receiving myelosuppressive chemotherapy for cancers in which cure is anticipated.” Medpagetoday.com. “FDA Commands Amgen to Change Darbepoetin Alfa (Aranesp) Label.“ 2008. http://www.medpagetoday.com/Product Alert/Prescriptions/tb/10358 (31 July 2008). Problem Rx Dizziness caused by combination therapy? Q A 63-year-old black male visits his cardiologist complaining of dizziness. He also gets blurred vision when using his computer. He has a history of hypertension and congestive heart failure, and is on multiple medications, including a diuretic, an ACE inhibitor, and a beta blocker. The cardiologist added isosorbide dinitrate/ hydralazine hydrochloride (BiDil) to his drug profile. Could this combination drug cause the patient’s side effects? A. Yes, dizziness is a common side effect to this drug, as are headaches. Blurred vision has been reported as a less common side effect to isosorbide dinitrate/hydralazine hydrochloride. The patient discontinued the drug, and four days later, his symptoms resolved. The physician is seeing the patient frequently in his heart clinic, and reports he is currently stable and continues to tolerate his other heart-failure medical regimen. Anand, I. S., et al. (2007). Influence of blood pressure on the effectiveness of a fixed-dose combination of isosorbide dinitrate and hydralazine in the African-American Heart Failure Trial. J Amer Coll Card, 49(1), 32. Bidil for heart failure. (2005). Med Letter, 47(1218), 77. Linda M. Porterfield, RN, PhD, is a clinical pharmacologist and director of cardiovascular research at Arrhythmia Consultants PC, in Memphis. She works with Thomas Motley, Sr., MD, who took part in the African-American Heart Failure Trial. November 2008 Healthcare Traveler 41 Circle Career Card No. 650 http://www.Medpagetoday.com http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/10358 http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/10358 http://www.Waldenuhealth.com http://www.Waldenuhealth.com http://www.Waldenuhealth.com http://www.ncahlc.org

Table of Contents Feed for the Digital Edition of Healthcare Traveler - November 2008

Healthcare Traveler - November 2008 Editor’s Desk Contents In a Flash Paws for Thought Field Notes You Said It Perks and Preferences A Latitude Adjustment Drug Update Clinical Tips Advice of Counsel Cityscape Advertiser’s Index Name It When In. . . It’s in the Bag Contest Rules Big Deals Tax Facts Going the Distance Allied Corner Classifieds Tales from the Road

Healthcare Traveler - November 2008

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