Pharmacy & Therapeutics - February 2009 - (Page 68)

NEW DRUGS nosed at birth. Children with the defect must curtail activities because of the risk of bleeding from minor trauma. This IV product is made from the plasma of healthy human blood donors and is indicated for patients who lack fi brinogen or who have levels below 50 mg/dL (the normal concentration is 250 to 400 mg/dL). The product is not indicated for those patients who have normal fibrinogen levels but defective fibrinogen function. Source: FDA, January 16, 2008 DRUG NEWS syndrome in newborn infants because benzyl alcohol has been eliminated. For the first time, IV amiodarone is available in a premixed, ready-to-use formula. Source: www.pharmpro.com, January 5, 2009 Source: Novartis, December 22, 2008; www.reclast.com Imatinib (Gleevec) Prevents Rare GI Cancer Recurrence Imatinib mesylate (Gleevec, Novartis) is now indicated for suppressing tumor growth after surgical removal of a gastrointestinal (GI) stromal tumor (GIST). GIST is a rare form of cancer that originates in cells in the wall of the GI tract. First approved by the FDA in 2001, imatinib blocks cellular communications that result in tumor growth. Because symptoms of GIST do not differ from other GI complaints such as nausea and vomiting, early detection is difficult. Patients may need surgery to remove the tumor, but GIST commonly recurs. In a clinical trial, patients received either imatinib or a placebo for one year after surgery. There were significantly fewer recurrences of GIST in patients receiving imatinib than in patients who did not receive it. Source: FDA, December 19, 2008 DRUG NEWS Fentanyl (Duragesic) Pain Patches Recalled Johnson & Johnson’s PriCara division has recalled two lots of fentanyl patches (Duragesic) because of tears in the products that could expose users to the gel, causing an overdose. J&J had issued a similar recall in February 2008 for a less potent dosage (25-mcg/hour patches). Fentanyl is a potent opioid pain reliever. Direct skin exposure to the gel in the patch can lead to respiratory problems and a fatal overdose. Alza Corp., an affiliate of PriCara, manufactured the patches being recalled. Duragesic 50 mcg/hour patches (Lot No. 0817239) and 50-mcg/hour patches (Lot No. 0816851), made by Sandoz, are being recalled. Other patches, in strengths of 12.5, 25, 75 and 100 mcg/hour, are not affected. PriCara urges anyone who comes in contact with fentanyl gel to wash exposed skin thoroughly with water only. Patches with cut edges should be carefully disposed of and not be handled directly. Source: Associated Press, December 31, 2008 NEW INDICATIONS Zoledronic Acid (Reclast) For Men with Osteoporosis An injectable form of zoledronic acid (Reclast, Novar tis) to increase bone mass can be used for men with osteoporosis. Although many view this bonethinning disease as affecting women primarily, 25% of men older than 50 years of age experience osteoporosis-related fractures. If a man has a hip fracture, he is twice as likely as a woman to die in the following year because of complications. However, fewer than 3% of men with osteoporosis receive treatment. A two-year, double-blind, head-to-head trial involving more than 300 men with osteoporosis was conducted to compare Reclast with an oral weekly bisphosphonate. Reclast increased lumbar spine bone mineral density (BMD) by 6.1% over two years and was non-inferior to the active control. Reclast was approved in 2007 for treating postmenopausal osteoporosis and Paget’s disease of bone. In June 2008, the medication was also approved to reduce new fractures in patients experiencing a recent low-trauma hip fracture. Reclast is given once a year at a dose of 5 mg. Zoledronic acid, also available as Zometa, is administered as an injection every three to four weeks to treat some cancers. NEW FORMULATION IV Amiodarone (Nexterone) For Cardiac Arrhythmias The FDA has approved a New Drug Application (NDA) for amiodarone HCl (Nexterone Injection, Prism Pharmaceuticals). Wyeth originally marketed this cosolvent-free formulation of intravenous (IV) amiodarone as Cordarone Intravenous. Nexterone is indicated for treating and preventing recurrent ventricular fibrillation and unstable ventricular tachycardia in patients who have not responded to other therapies. Nexterone overcomes the solubility problems associated with amiodarone. With polysorbate 80 and benzyl alcohol removed, the new product is more compatible and stable with plastics and ionic infusion fluids. Nexterone does not carry a warning about the risk of fatal gasping Harm from Antipsychotic Drugs in Two Studies Alzheimer’s Disease and Dementia Patients with Alzheimer’s disease (AD) who take antipsychotic drugs seem to have a higher risk of death than similar patients who do not take these agents, according to a British report. Using antipsychotic agents for a short time can be beneficial, but prolonged use can cause Parkinson-like symptoms, 68 P&T® • February 2009 • Vol. 34 No. 2 http://www.reclast.com http://www.pharmpro.com

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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

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