Pharmacy & Therapeutics - May 2008 - (Page 265) NEW DRUGS safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment). (Source: FDA, April 8, 2008.) DRUG NEWS tions on the use of anemia drugs such as Amgen’s Epogen and Aranesp and Johnson & Johnson’s Procrit for cancer patients. The revised regulations address patients’ rights, patients’ safety, and their participation in health care procedures. Epogen is used to treat anemia in patients undergoing kidney dialysis, and Aranesp is used in patients with kidney disease and cancer patients undergoing chemotherapy. Under a license from Amgen, J&J sells Procrit for treating cancer patients. The drugs are genetically engineered versions of erythropoietin. (Sources: Reuters, April 3, 2008; CMS, www.cms.hhs.gov.) Vyvanse for ADHD in Adults The FDA has approved Shire’s lisdexamfetamine dimesylate (Vyvanse) for treating Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. Introduced in July 2007 for the treatment of ADHD in children 6 to 12 years of age, it is now the first once-daily prodrug stimulant approved to treat adults with ADHD. Vyvanse is now available in strengths of 30 mg, 50 mg, and 70 mg for oncedaily dosing: Dosage strengths of 20 mg, 40 mg, and 60 mg are expected to be available in pharmacies this summer. (Sources: FDA, April 23, 2008; www. vyvanse.com.) cough medication, Tussionex Penn kinetic Extended-Release Suspension (UCB) in response to reports of adverse events, including death. The product contains hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The alert does not apply to short-acting hydrocodone cough products that can be given every four to six hours. (Source: FDA, March 13, 2008.) Revised Dosing For PegIntron/Ribavirin In Hepatitis C The FDA has approved label revisions for Schering-Plough’s combination agent peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) for chronic hepatitis C virus (HCV) infection. The revised label includes recommendations for weight-based dosing of Rebetol (800– 1,400 mg daily) and recommends a shorter, 24-week course of the combination for patients with chronic HCV genotype 2 or 3. In the U.S., PegIntron is indicated for use alone or with Rebetol for treating chronic HCV in patients with compensated liver disease who have not used interferon-alpha and who are at least 18 years of age. The label changes were based on the results of the WIN-R trial (Weight-Based Dosing of PegIntron and Rebetol), which showed higher sustained virological responses, when compared with PegIntron plus a flat 800-mg daily dose of Rebetol (the previously accepted dose). (Source: FDA, March 27, 2008.) AIDS Drugs And Heart Attack Risk In a European study, an antiretroviral drug used to fight AIDS, GlaxoSmithKline’s abacavir (Ziagen), appeared to double the risk of a heart attack. Didanosine (Videx, Bristol-Meyers Squibb), a less commonly used agent, also increased heart attack risk by about 50%. Researchers from the University of Copenhagen analyzed data from more than 33,000 patients with HIV infection in Europe, the U.S., and Australia who were enrolled from 1999 to 2005. The authors looked for heart problems that occurred before February 2007. Of 517 patients who had heart attacks, 124 had recently taken didanosine and 192 had recently taken abacavir. Patients taking abacavir had twice the chances of a heart attack compared with those using other antiretroviral agents. Those using didanosine had a 50% higher risk, but the risk disappeared six months after patients stopped taking the drugs. GlaxoSmithKline did not agree with the study and noted that abacavir does not increase lipids or glucose levels. Patients who smoke or who are obese are already susceptible to heart problems and may face the highest risk. In DRUG NEWS Recalled: Rotigotine (Neupro), Parkinson Patch Schwarz Pharma has announced the recall of Neupro, a transdermal delivery system worn on the skin to treat earlystage Parkinson’s disease, because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less of the drug is available to be absorbed through the skin and the efficacy of the product may vary. Health care professionals should not prescribe the patch for new patients, and they should start lowering the dose for patients who are currently using the product. Patients should not abruptly discontinue therapy because of the possibility of neuroleptic malignant–like syndrome or an akinetic crisis. (Source: FDA, April 9, 2008.) New Medicare Guidelines For Erythropoietin in Dialysis The Centers for Medicare and Medicaid Ser vices (CMS) has completed guidelines for kidney dialysis patients that do not include changes in anemia treatment. Last year, the agency had set restric- Alert for Tussionex, A Cough Medication The FDA has issued an alert concerning the safe and correct use of a potent Vol. 33 No. 5 • May 2008 • P&T® 265 http://www.cms.hhs.gov http://www.vyvanse.com http://www.vyvanse.com
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