Pharmacy & Therapeutics - April 2008 - (Page 205) NEW DRUGS Two New Tests For Colorectal Cancer The American College of Radiology and American Cancer Society have updated their guidelines to include stool DNA and virtual colonoscopy as a screening examination for colorectal cancer. (Source: The New York Times, March 6, 2008.) DRUG NEWS light produced is measured. With the help of calibrators, the physician can determine whether antibody to hepatitis B core antigen (anti-HBc) IgM is present in the patient’s blood. The Architect Core-M reagent kit, calibrators, and controls must be used to detect antibodies associated with HBV infection. Purpose: The presence of antibodies can help determine whether patients currently have or have had HBV infection. This in vitro test is not intended for screening blood, plasma, or tissue donors. A nonreactive test does not exclude the possibility of exposure to or infection with HBV. Benefit: The results reveal the stage of infection and suggest the correct treatment. Sources: FDA, www.fda.gov; www. abbottdiagostics.com Device Alert: Balloon Catheters In January 2008, Cordis Dura Star RX and Fire Star RX PTCA balloon catheters were recalled. The recall affects catheters made in Mexico from February 2007 through December 2007 that were distributed worldwide from March 26, 2007, through January 8, 2008. The Dura Star RX was distributed in the U.S. on August 29, 2007, and Fire Star RX was distributed in the U.S. on August 31, 2007. All Fire Star and Dura Star lots 13173912 through 13315455, as well as 52 additional lots above 13315455, are affected. No lots above 13329055 are involved. The product has a potential for slow or no deflation of the angioplasty balloon upon insertion into the artery or other blood vessels. This defect may cause a total blockage of the artery or blood vessels, resulting in altered heart rate or heart rhythm, injury to the heart artery, a heart attack, the need for a surgical procedure, or death. Source: FDA, January 14, 2008, www. fda.gov I NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name: Epic Stented Tissue Valve with Linx Anti-calcification Technology Manufacturer: St. Jude Medical, Inc., St. Paul, Minn. Approval Date: October 26, 2007 Use Classification: The Epic valve is used to replace faulty heart valves during heart surgery. Most patients who undergo heart valve replacement annually receive tissue valves. The device was approved following a study to evaluate its safety and efficacy, as measured by its ability to handle blood flow, the patient’s ability to perform everyday activities, and adverse effects. Description: Identical in design to the company’s Biocor valve, the Epic valve also incorporates anti-calcification technology, which protects against tissue mineralization (hardening). Purpose: The valve is designed to deliver long-term performance, and its durability is af fected by mechanical stress and tissue calcification. Benefit: The low overall height of the valve makes it easier to implant. The valve is available in aortic, aortic supra, and mitral models. In the mitral position, the valve’s low profile reduces the risk of obstructing blood flow into the aorta. In the aortic position, the valve helps provide optimal clearance of the coronary ostia (openings) and reduces the risk of aortic wall protrusion. Sources: www.pharmacyonesource. com; www.businesswire.com Name: Tru Flu and Tru RSV Upper Respiratory Tests Manufacturer: Meridian Bioscience, Inc., Cincinatti, Ohio Approval Date: October 26, 2007 Use Classification: The Tru Flu test detects both influenza A and influenza B, and the Tru RSV test is used to detect respiratory syncytial virus. Description: Both tests are based upon a rapid technology that features improved safety for diagnosing common upper respiratory diseases. More than 200,000 people are likely to be hospitalized because of influenza, and approximately 36,000 people die each year. RSV is the most common cause of severe respiratory illness in small children. Purpose: The tests provide accurate results and can be used simultaneously to evaluate specimens from the same patient. Benefits: The rapid diagnosis of influenza enables physicians to prescribe antiviral medications promptly and to avoid prescribing antibiotics that have no effect on influenza or RSV. The Tru tests limit the number of rapid tests that have to be repeated. Up to six tests can be run with just one card, and more than one test can be run at a time. Sources: www.pharmacyonesource. com; www.meridianbioscience.com Name: Architect Core-M Test for Hepatitis B Virus Manufacturer: Abbott Laboratories, Abbott Park, Ill. Approval Date: November 6, 2007 Use Classification: This laboratory test is used to detect antibodies associated with hepatitis B (HBV) infection. Description: A sample of the patient’s blood is combined with anti-human immunoglobulin M (IgM)–coated paramagnetic microparticles to form antibody–antigen complexes. These complexes then react with other substances to produce a light effect. The amount of Vol. 33 No. 4 • April 2008 • P&T® 205 http://www.fda.gov http://www.abbottdiagostics.com http://www.abbottdiagostics.com http://www.pharmacyonesource.com http://www.meridianbioscience.com http://www.pharmacyonesource.com http://fda.gov http://www.pharmacyonesource.com http://www.businesswire.com http://fda.gov http://www.pharmacyonesource.com
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