Pharmacy & Therapeutics - June 2008 - (Page 330)

NEW DRUGS nist that suppresses testosterone production and reduces prostate-specific antigen (PSA) levels. The growth of the prostate gland is regulated in part by testosterone levels. New features include a smaller 21gauge needle for improved patient comfort, reconstitution without the use of a needle, and a shield that covers the needle before and after the drug is given. Trelstar is available in a four-week depot form and a 12-week long-acting form. It should be stored at room temperature. Trelstar may initially cause a temporary increase in testosterone levels, and symptoms may worsen during this period. Cases of anaphylactic shock and angioedema have been reported. Approved in 2001, Trelstar was developed by Debiopharm and was also indicated for endometriosis in women. (Source: Watson, April 30, 2008.) DRUG NEWS infection was eradicated in all 15. When 17 patients were given other intravaginal medications, such as a Betadine (Purdue) douche and clotrimazole (Lotrimin, Schering), the infection was eradicated in only five women. Eighteen women were not treated. Few adverse effects were noted. One woman who received oral metronidazole desensitization developed a pruritic rash on the final day. Another who received IV metronidazole desensitization experienced mild urticaria and pruritus 45 minutes after the final 2-g dose, and she was managed with diphenhydramine (Benadryl, McNeil/Johnson & Johnson). (Source: Am J Obstet Gynecol 2008;198: 370e1–370e7.) the 5-mg daily dose. Similar increases in bone mineral density were seen among patients taking either regimen. (Sources: FDA, April 24, 2008; www. actonel.com.) DRUG NEWS Digoxin Tablets Recalled Actavis Totowa LLC (formerly Amide) is initiating a Class I nationwide recall of all strengths of oral digoxin tablets, USP (Digitek). Mylan distributes the products under a Bertek label, and UDL Laboratories, Inc., distributes them under a UDL label. It is possible that tablets with twice the appropriate thickness might have been released. Digitek is used to treat heart failure and arrhythmia. A double-strength tablet poses a risk of digitalis toxicity in patients with renal failure. Retailers should return the product to their place of purchase, and consumers should contact their health care providers. (Sources: FDA, April 25, 2008; www. activis.us.) Drug-Eluting Stents Benefit the Elderly Although octogenarians are considered to be at high risk for many operative procedures, drug-eluting stent implantation shouldn’t be one of them, say Mayo Clinic researchers. In a study of 2,453 patients, the stents were successful 98% of the time in subjects older than 80 years of age, even with their higher prevalence of comorbidities and multivessel disease. During the 12 months after discharge, mortality rates were higher in the octogenarians (9% vs. 3% in younger patients) and occurred more often from cardiac causes—but life expectancy was similar to that of the general population. There was no significant difference in 12-month target lesion revascularization or coronary artery bypass grafting. (Source: Am Heart J 2008;155:680– 686.) Factor VIIa (NovoSeven RT) Coagulation Therapy The FDA has approved a new formulation of the genetically engineered version of factor VIIa (NovoSeven RT, Novo Nordisk), a plasma protein essential for the clotting of blood. NovoSeven RT can be stored at room temperature (up to 77° F) for up to two years, an advantage for health care facilities with limited refrigeration space. The original formula could be stored for three years at temperatures between 36° and 46° F. (Source: FDA, May 8, 2008.) Treating Trichomonas Infection Approximately 3% of women have Trichomonas vaginalis, the most common nonviral sexually transmitted disease in the U.S. Two chemically similar drugs are recommended for treating this infection: metronidazole (Flagyl, Pfizer) and tinidazole (Tindamax, Mission Pharmacal). However, if the patient is hypersensitive to either or both drugs, alternatives are few. One answer might be incremental dosing, or desensitization, of oral and IV metronidazole. Researchers from the Centers for Disease Control and Prevention (CDC) analyzed data from 59 infected women who had reactions such as urticaria and facial edema when they received metronidazole. Fifteen women were treated with metronidazole desensitization, and the NEW DOSAGE Once-Monthly Risedronate (Actonel) for Osteoporosis The FDA has approved Procter & Gamble’s new once-a-month dose (150 mg) of risedronate sodium (Actonel) tablets for the treatment and prevention of postmenopausal osteoporosis. This approval was based on a study comparing the 150-mg once-monthly dose with … But Thrombosis Occurred in Another Stent Study Rates of late thrombosis, a concern with drug-eluting stents, have been variously reported at less than 1% and at more than 2%. Researchers from Spain 330 P&T® • June 2008 • Vol. 33 No. 6 http://www.actonel.com http://www.actonel.com http://www.activis.us http://www.activis.us

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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