Pharmacy & Therapeutics - November 2008 - (Page 629)

NEW DRUGS a response to the intense time pressure of rapid reperfusion, which might deter clinicians from taking the time to consider a patient’s body weight. Heparin’s effects are also discussed in this month’s cover stor y on heparininduced thrombocytopenia on page 642. (Source: Am J Med 2008;121:805–810.) DRUG NEWS clots are two common adverse events associated with heart-assist devices. (Source: FDA, October 9, 2008.) Adverse Effects With Formoterol (Foradil) Aerolizer For Asthma Asthma patients who use the beta2agonist formoterol fumarate (Foradil Aerolizer, Schering) are more likely to experience nonfatal serious adverse events than patients given placebos. A significantly increased risk occurred when formoterol was taken once or twice daily for at least 12 weeks. Long-acting beta2-agonists are inhaled and last for 12 hours or more, but their long-term use is controversial. Recent research had also cast doubt on the safety of salmeterol (Serevent Diskus, GlaxoSmithKline). The increase in adverse events was more pronounced in younger patients. (Source: Cochrane Database Syst Rev 2008 [4]. Article No. CD006923.) investigation by FDA into the antibiotic’s alleged risks. Although the FDA has addressed the potential for liver damage among patients and relabeled the drug, citing significant dangers associated with consuming the antibiotic, millions of people are still using this drug. Other adverse events have included bradycardia, low potassium and magnesium levels, QTc prolongation, hepatitis, myasthenia gravis, and kidney disease, according to the Mayo Clinic. (Source: TransWorld News, October 12, 2008, www.transworldnews.com.) AlloMap, a Test For Heart Transplant Patients The FDA has approved a noninvasive test (AlloMap, XDx, Inc.) to assess the potential for organ rejection in hearttransplant recipients after surgery. AlloMap measures genetic information contained in the patient’s white blood cells. (Source: FDA, August 28, 2008.) NEW MEDICAL DEVICES DEVICE APPROVALS Drug-Eluting Stent For Small Coronary Vessels Boston Scientific Corporation has received approval to market its Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System. This drug-eluting stent is used to treat coronary vessels as small as 2.25 mm in diameter. The FDA has also approved the company’s Taxus Express2 Paclitaxel-Eluting Coronary Stent System for treating in-stent restenosis after the use of bare-metal stents. (Source: Boston Scientific, September 25, 2008.) Marvin M. Goldenberg, PhD, RPh, MS Name: iFS Advanced Femtosecond Laser Manufacturer: Advanced Medical Optics, Inc., Santa Ana, Calif. Approval Date: May 14, 2008 Use Classification: Laser-assisted in situ keratomileusis (LASIK) surger y involves creating a flap in the cornea with a microkeratome and using a laser to reshape the underlying cornea. The laser provides surgeons with the ability to choose flap dimensions custom-tailored to each patient’s refractive errors and corneal anatomy. An elliptical flap option, an inverted bevel-in side cut angle, and increased speed are featured. Description: An inverted bevel-in side cut angle provides a virtually effortless flap lift that increases flap adhesion and enhances the biomechanical stability of the cornea after LASIK surgery. Purpose: A corneal flap can be created during LASIK procedures in less than 10 seconds. Benefit: Features include a higher repetition rate; the need for less energy; a high-resolution digital video microscope; a new user interface, keyboard, and touch screen; and an ergonomic design for surgeon comfort. Sources: www.pharmacyonesource. com; www.amo-inc.com Telithromycin (Ketek) And Possible Liver Damage LegalView, an Internet Web site, is alerting patients about the potentially fatal side effects linked to telithromycin (Ketek, Sanofi-Aventis). Some signs of toxicity associated with this antibiotic have include jaundice and other liver problems, including liver failure. Telithromycin is used to treat respiratory infections. It was approved in 2004 and was part of a new class of drugs known as antimicrobial agents that “circumvent antibiotic resistance.” After only two years on the market, reports began to sprout about the drug causing severe liver failure among patients, spawning an Temporary Pump For the Heart’s Right Side The FDA has approved a Humanitarian Device Exemption for a heart pump that provides critically ill patients with temporary support for the right side of the heart. Most heart-assist devices support the heart’s left ventricle. The CentriMag Right Ventricular Assist System (Levitronix) system can be used for up to 14 days to keep patients alive until the heart recovers or until a heart or a long-term heart-assist device can be implanted. Severe right-sided heart failure is uncommon but can be fatal. Patients who cannot take anticlotting agents should not use this device; bleeding and blood Vol. 33 No. 11 • November 2008 • P&T® 629 http://www.transworldnews.com http://www.pharmacyonesource.com http://www.amo-inc.com http://www.pharmacyonesource.com

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Pharmacy & Therapeutics - November 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Heparin-Induced Thrombocytopenia Medication Utilization Patterns and Hypertension-Related Expenditures among Patients Who Were Switched From Fixed-Dose to Free-Combination Antihypertensive Therapy European Society for Medical Oncology and Association for the Study of Bone and Mineral Research Pharmaceutical Approval Update

Pharmacy & Therapeutics - November 2008

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