Drug Topics - January 21, 2008 - (Page 6) 6 DRUG TOPICS JANUARY 21, 2008 www.drugtopics.com > > > NEWS Roundup Rx Care Two more studies show EPO drugs not safe for cancer patients The FDA http://www.fda.gov has issued yet another press release on the use of erythropoiesis-stimulating agents (ESAs) to treat anemia in cancer patients. Two new studies provide additional evidence that patients with cancer taking ESAs died sooner or had more rapid tumor growth than patients who did not receive the drugs. These new studies were not among the six previous studies that had similar findings and were the basis for the revised labeling in November 2007 for Aranesp (Amgen), Epogen (Amgen), and Procrit (OrthoBiotech). The FDA said it plans to further review the results and discuss the use of ESAs in patients with chemotherapy-induced anemia at a public advisory committee in a few months. Also, patients with kidney disease should be counseled on appropriate protein intake since high-protein diets can worsen the condition. The updated guidelines also include new information on diabetes testing and treatment recommendations for older adults. More information can be found at www.diabetes.org. Government/Law FDA requires new toll-free number for reporting adverse events As of Jan. 1, FDA is requiring a toll-free number to be listed on the labeling of human drugs for the reporting of adverse events. The number is to be used only for reporting side effects and not for seeking medical advice. This interim final rule, published in the Jan. 3 Federal Register, does not apply to over-the-counter drugs if the product packaging includes a manufacturer’s or distributor’s toll-free number for reporting complaints. Realizing that manufacturers and pharmacies will need time to update their labeling to comply with this new requirement, FDA said it would not take enforcement action on this matter until Jan. 1, 2009. The agency added that the side effect statement has to be distributed by pharmacists with each new and refill prescription either through a sticker on the unit package, vial, or container; a preprinted Rx vial cap; a separate sheet of paper; consumer medication information; or a medication guide. Blood volume expander gets FDA nod Voluven, manufactured by German company Fresenius Kabi, has received an FDA approval for restoring blood volume following surgery. The new intravenous product contains 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection and has proven to be as safe and effective in expanding blood volume as Hespan (B. Braun Medical) during orthopedic surgery. The new solution was also studied in newborns and infants. The synthetic starch molecules contained in the product do not dissolve in water and are linked together and combined with a salt solution in a concentration similar to human blood. According to the company, a clinical trial to study Voluven in patients with sepsis is planned. FDA to consumers: Don’t take supplements for ED, sexual enhancement FDA has notified consumers and healthcare professionals not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojmengnan) products. The products are marketed as dietary supplements and used for the treatment of erectile dysfunction (ED) and for sexual enhancement. The products do not qualify as dietary supplements because they contain undeclared active ingredients (sildenafil or an analog of sildenafil) of FDA-approved prescription drugs for ED. The products are thus drugs that are illegal because they lack FDA approval. Additionally, because the manufacturing source of the active in- New ADA guide gives equal weight to low-carb, low-fat dieting The 2008 “Standards of Medical Care in Diabetes,” from the American Diabetes Association (ADA) states that there is growing evidence that both low-fat and low-carbohydrate dieting are equally safe and effective for reducing short-term weight loss (up to one year). The most important determinant of weight loss, according to the new guide, is the patient’s ability to stick to the program and not the composition of the diet. Previously, the ADA had not recommended low-carb diets due to a lack of scientific evidence supporting their safety and efficacy. The ADA also stated that patients on low-carb weight-loss programs should monitor their lipid profiles since replacing calories from carbohydrates with fat or protein could affect lipid levels. Photo: Jim Shive http://www.drugtopics.com http://www.fda.gov http://www.diabetes.org
Table of Contents Feed for the Digital Edition of Drug Topics - January 21, 2008 Drug Topics - January 21, 2008 Contents Medication Errors: The Value of Habit FDA Official: Biomarkers Can Change the Future Latest News Roundup Drug Topics - January 21, 2008 Drug Topics - January 21, 2008 - Contents (Page 1) Drug Topics - January 21, 2008 - Contents (Page 2) Drug Topics - January 21, 2008 - Contents (Page 3) Drug Topics - January 21, 2008 - Medication Errors: The Value of Habit (Page 4) Drug Topics - January 21, 2008 - FDA Official: Biomarkers Can Change the Future (Page 5) Drug Topics - January 21, 2008 - Latest News Roundup (Page 6) Drug Topics - January 21, 2008 - Latest News Roundup (Page 7) Drug Topics - January 21, 2008 - Latest News Roundup (Page 8)
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