Drug Topics - February 4, 2008 - (Page 5) www.drugtopics.com FEBRUARY 4, 2008 DRUG TOPICS 5 Rx Care Leukine withdrawn from market due to EDTA-related adverse events Bayer HealthCare Pharmaceuticals has announced the withdrawal of growth factor sargramostim (Leukine) following an upward trend in adverse events (including syncope) in patients receiving the liquid formulation of the product. According to the company, the adverse reactions are thought to be due to the edetate sodium (EDTA) that is contained in the liquid product. Bayer said it will reformulate the liquid to eliminate EDTA. In the meantime, the company will establish a special access program for distribution of lyophilized sargramostim, which does not contain EDTA and is not associated with the reported adverse events. The program will be an interim step to provide priority access to the lyophilized drug until adequate supply can be manufactured and the liquid reformulated. Information on returning affected inventory and questions regarding the access program can be found online at www.pharma.bayer.com or by calling 1-(888)-842-2947. macies with affected inventory should contact Baxter Healthcare Center for service at (888) 229-0001 and arrange for return and credit. Diabetes called a growing public health crisis New data from the American Diabetes Association reveal that the costs associated with diabetes have jumped by 32% since 2002, to $174 billion annually. One out of every five healthcare dollars is spent on caring for someone diagnosed with diabetes. ADA added that six million people are believed to have diabetes but have not been diagnosed yet. These grim statistics underscore the need for early diagnosis and treatment of this condition. Few people are taking advantage of immunizations Although there are now 17 diseases that can be prevented from vaccines given to children, teens, and adults, uptake on these prophylactic measures is low. That’s the message from a press conference held by the National Foundation for Infectious Diseases (NFID). According to new data released by the Centers for Disease Control & Prevention, only 1.9% of the elderly are immunized against shingles and only 2.1% of adults from 18 to 64 years of age have received the tetanus-diphtheria-whooping cough vaccine. Besides these two vaccines, immunization can also be obtained for chickenpox, hepatitis A and B, HPV, influenza, measles, meningococcal disease, mumps, pneumococcal disease, and rubella. NFID officials called for a concerted effort to raise adult immunization rates to reduce morbidity and mortality. New HIV drug approved on accelerated basis Tibotech Therapeutics’ Intelence (etravirine) has been approved on an accelerated basis by the FDA for HIV combination therapy. The tablet is the first new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be introduced in nearly 10 years and also the first NNRTI to show antiviral activity in patients with NNRTI-resistant virus. As such, it breaks new ground in the treatment of HIV patients, said Tibotec, a division of Ortho-Biotech Products. Once-daily amoxicillin approved MiddleBrook Pharmaceuticals’ Moxatag (amoxicillin extended-release) Tablets 775 mg have been approved to treat adults and children 12 and older with pharyngitis and/or tonsillitis secondary to strep throat. The Germantown, Md., firm claims that its product is the first once-daily amoxicillin product approved in this country. Its convenient dosing should ensure better drug compliance. Heparin injection recalled as Baxter investigates Reported adverse events associated with Baxter’s heparin sodium injection 1000 units/ml have prompted the company to recall certain lots of the product while it investigates the cause. The affected lots include both 10ml and 30-ml vials. The 10-ml vials affected are from lots 107054 and 117085. The 30-ml vials affected include lots 047056, 097081, 107024, 107064, 107066, 107074, and 107111. A complete list of reported adverse events can be found at www.fda.gov/medwatch/ safety/2008/Heparin_recall_01-17-2008.pdf. Phar- Humira receives FDA approval for psoriasis Biologic adalimumab (Humira, Abbott) has been approved by the FDA for a fifth indication – the treatment of moderate to severe chronic plaque psoriasis. The approval was based on results of two trials that showed marked improvement in skin condition. Almost three >>> NEWS Roundup http://www.drugtopics.com http://www.drugtopics.com http://www.pharma.bayer.com http://www.fda.gov/medwatch/safety/2008/Heparin_recall_01-17-2008.pdf http://www.fda.gov/medwatch/safety/2008/Heparin_recall_01-17-2008.pdf
Table of Contents Feed for the Digital Edition of Drug Topics - February 4, 2008 Drug Topics - February 4, 2008 Medication Errors: A Plan for Quality Can You Explain Pharmacy to an Eighth Grader? Latest News Roundup Drug Topics - February 4, 2008 Drug Topics - February 4, 2008 - Drug Topics - February 4, 2008 (Page 1) Drug Topics - February 4, 2008 - Drug Topics - February 4, 2008 (Page 2) Drug Topics - February 4, 2008 - Medication Errors: A Plan for Quality (Page 3) Drug Topics - February 4, 2008 - Can You Explain Pharmacy to an Eighth Grader? (Page 4) Drug Topics - February 4, 2008 - Latest News Roundup (Page 5) Drug Topics - February 4, 2008 - Latest News Roundup (Page 6)
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