Pharmacy & Therapeutics - October 2008 - (Page 572)

NEW DRUGS to delays in antifungal treatment. Patients taking TNF-α blockers should be informed that they are more susceptible to serious fungal infections. To assist in diagnosis, patients should tell their health care professionals where they live and where they have recently visited. The FDA has reviewed 240 reports of histoplasmosis, an infection caused by Histoplasma capsulatum, in patients using etanercept, adalimumab, or infliximab. In at least 21 of these reports, health care providers did not initially recognize histoplasmosis. Twelve of those patients died. Most patients lived in the Ohio River and Mississippi River valleys. (Source: FDA, September 4, 2008.) DRUG NEWS creased susceptibility to infection. In a trial of 68 patients, Caphosol was associated with low rates of oral mucositis and appeared to relieve pain and dysphagia. Compliance was high, and only two patients discontinued treatment. Caphosol is also indicated for dryness of the mouth or throat. Patients who must follow a low-sodium diet should consult their health care providers before using this product and should avoid eating or drinking at least 15 minutes after using it. (Source: EUSA, www.eusapharma. com.) Can Lithium Slow Down ALS? The ALS Association is funding a major clinical trial to determine whether lithium can slow disease progression in patients in the early stages of amyo trophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. Funding partners for the trial include the National Institute of Health/National Institute of Neurologic Diseases and Stroke, and the ALS Society of Canada. ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord, leading to progressive paralysis. Lithium, approved for use as a mood stabilizer, was shown to protect neurons in the brain in animal models of neurodegenerative diseases, including Alzheimer’s disease and Parkinson’s disease and had the same ef fect in a mouse model of ALS. In that study, lithium prolonged survival and protected cells in the brain and spinal cord. Researchers think that lithium helps clear toxic protein accumulation. In the new trial, 84 patients will receive either lithium or placebo for one year. (Source: ALS Association, August 26, 2008, www.alsa.org.) NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name: Advance System Manufacturer: NeuroMetrix, Inc., Waltham, Mass. Approval Date: April 28, 2008 Use Classification: Advance is a comprehensive platform that can be used by physicians to perform nerve-conduction studies and invasive electromyography. Description: A precision electrical stimulator and dual recording channels are included to acquire nerve-conduction responses. A third channel is available for recording needle electromyography signals. Purpose: The system offers a way to perform nerve-conduction studies. Benefit: The software provides physicians with accurate and reliable nerveconduction parameters. Technological improvements include power from a high-capacity lithium-ion battery, which adds convenience. The amplification and digitization hardware reduces susceptibility to electrical interference and makes the device suitable for use in all settings, even in intensive-care units. A high-resolution, color touch screen facilitates real-time review and editing of waveforms. Integrated Bluetooth provides wireless communication with data FDA Consumer Web Site For Drug Ads EthicAd, a nonprofit organization devoted to improving public health through consumer education, has announced the launch of a new FDA Web site created to familiarize the public with direct-to-consumer (DTC) advertising of prescription medications. The site, called “Be Smart about Prescription Drug Advertising,” is hosted by the FDA’s Center for Drug Evaluation and Research, and it was developed by the FDA in partnership with EthicAd. The Web site explains the content that patients should expect to see in the ads and includes a checklist for patients so that they can discuss the advertised products with their physicians. A section for soliciting feedback from the public is also included. EthicAd was founded by the late noted heart surgeon and Congressional Gold Medal recipient Dr. Michael E. DeBakey. The organization does not receive any funding from the pharmaceutical industry. (Sources: EthicAd, September 5, 2008; FDA, www.fda.gov.) Oral Rinse (Caphosol) Alleviates Oral Mucositis An electrolyte solution, Caphosol, has been found to limit the occurrence and severity of oral mucositis in cancer patients undergoing chemotherapy and radiation therapy. Findings were discussed in September at a meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO). Almost 97% of patients with cancers of the head or neck receiving radiation therapy involving the oral cavity experience oral mucositis, which can result from erosion of epithelial cells in the oral cavity during therapy. Patients experience pain, difficulty eating and swallowing, and in- 572 P&T® • October 2008 • Vol. 33 No. 10 http://www.eusapharma.com http://www.eusapharma.com http://www.alsa.org http://www.fda.gov

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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