Pharmacy & Therapeutics - February 2009 - (Page 106)

NEW DRUGS older. The tool should help physicians and patients decide when and how to screen. After the patient’s personal and family medical history, lifestyle behaviors, and age are input, the risk is determined. The device is not suitable for patients with ulcerative colitis, Crohn’s disease, familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or a history of colorectal cancer. Sources: J Clin Oncol, December 29, 2008; NCI, January 5, 2009 DRUG NEWS Approval Date: November 19, 2008 Use Classification: The FiberNet system is used to treat carotid artery disease. Description: The system captures debris released during stenting and prevents it from traveling to the brain, where it has the potential to cause a stroke. The defining attribute of the FiberNet filter lies in its three-dimensional design, composed of a matrix of fibers, allowing for better capture efficiency (more than 40 µm). The filter is mounted on a guide wire. Remote activation deploys the fiberbased filter to treat vessels ranging from 3.5 to 7 mm. Purpose: Carotid stenting can be an alternative to surgery for patients needing endvascular intervention. Benefit: The optimal filtration and ease of use of the FiberNet filter represent a significant advance in treating carotid arteries. Sources: www.pharmacyonesource. com; www.medicalnewstoday.com Device Recalls Energizer. The FDA has announced a Class 1 recall of the Vibrational Integrated Bio- photonic Energizer (Vibe Technologies), which claims to treat cancer, infections, and depression. The agency has not approved this device. One patient who used the energizer died, but the FDA has not verified a link between the death and the device. HLX8.This product, which is claimed to treat cancer, migraines, arthritis, and ruptured discs, has also been recalled. The FDA has not granted approval to Nebion LLC to market the device. Products that claim to diagnose, cure, mitigate, treat, or prevent disease or that are intended to affect the structure or function of the body are subject to the FDA’s jurisdiction and may require FDA approval before they may be sold. Source: FDA, December 15, 2008 I sure improved and no statistical difference was observed in either diastolic blood pressure or serum creatinine levels from the baseline evaluation through three years. After nine months, the binary restenosis rate was 21.3%. The low target lesion revascularization rate was 8.1%, and no stent thromboses occurred. Source: Medical News Today, www. medicalnewstoday.com Name: E-Luminexx Vascular Stent (Iliac Arteries) Manufacturer: Bard Peripheral Vascular, Inc., Tempe, Ariz. Approval Date: December 4, 2008 Use Classification: This stent is used to treat narrowing of the iliac arteries caused by atherosclerosis. Description: A thin, flexible metal mesh tube is implanted in the iliac arteries, which supply blood to the pelvis and legs. The stent, mounted onto a catheter, is held in place by an outer sheath until it is placed in the artery. When it is in place, the stent increases blood flow by holding the artery wall open. The stent remains permanently implanted in the iliac artery and supports the newly opened section of the artery. Purpose: The stent is used to keep the iliac artery open in order to maintain adequate blood flow. Precautions: The stent is contraindicated in patients with bleeding disorders and when stenoses cannot be dilated to permit passage of the delivery system. The device should not be used if leakage from an artery could be exacerbated by placement of a stent. Benefit: The stent improves blood flow to the pelvis and legs. Source: FDA, www.fda.gov Name: FiberNet Embolic Protection System (Carotid Arteries) Manufacturer: Lumen Biomedical, Inc., Plymouth, Minn. NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name: Express SD Monorail Premounted Stent System (Renal Arteries) Manufacturer: Boston Scientific Corp., Natick, Mass. Approval Date: December 15, 2008 Use Classification: The stent system is used as an adjunct to percutaneous transluminal renal angioplasty to treat lesions of the renal arteries. Description: Based on the Maverick Monorail Balloon Catheter technology and Tandem Architecture Stent Design, the system provides excellent support, especially in ostial lesions at the opening of the renal artery. Purpose: This is the first low-profile, premounted stent approved for use in renal arteries in the U.S. In patients with renal artery disease, the main blood supply to the kidneys is narrowed because of atherosclerosis. Plaque formation within the arteries can lead to hyper tension or impaired kidney function. Athero sclerotic disease can be treated surgically, with medication, or less invasively with angioplasty. Restenosis of the arteries can occur after angioplasty, and the use of stenting as an adjunctive treatment option is intended to assist in reopening these arteries. Benefit: The Express SD System provides additional proximal-end support. In a long-term study, systolic blood pres- 106 P&T® • February 2009 • Vol. 34 No. 2 http://www.medicalnewstoday.com http://www.medicalnewstoday.com http://www.pharmacyonesource.com http://www.pharmacyonesource.com http://www.medicalnewstoday.com http://www.fda.gov

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - February 2009

Pharmacy & Therapeutics - February 2009 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Pushing an Expanded Role for Pharmacists Better Asthma Management with Advanced Technology Pharmaceutical Approval Update 58th Annual Meeting, American Society of Human Genetics, 2008 American Society of Hematology, 50th Annual Meeting and Exposition 2008 San Antonio Breast Cancer Symposium Stahl’s Essential Psychopharmacology, 3rd Edition Author Guidelines

Pharmacy & Therapeutics - February 2009

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.