Drug Topics - February 4, 2008 - (Page 6) 6 DRUG TOPICS FEBRUARY 4, 2008 www.drugtopics.com NEWS Roundup out of four patients achieved skin clearance of 75% or better and nearly half achieved 90% clearance. According to Abbott, one in five patients experienced complete clearance of psoriasis plaques. Adalimumab was previously approved for the treatment of ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and Crohn’s disease. betes. The bile acid sequestrant was approved in 2000 alone or in combination with a statin to reduce elevated LDL-C in patients with primary hypercholesterolemia. The Parsippany, N.J., firm claims the product is the first and only medication approved to lower both glucose levels and low-density lipoprotein cholesterol. Direct renin inhibitor/diuretic combo gets FDA nod Combination antihypertensive, Tekturna HCT, has been approved by the FDA and contains both direct renin inhibitor aliskiren (Tekturna, Novartis) and diuretic hydrochlorothiazide in a single tablet. The approval was based on results of clinical trials involving more than 2,700 patients. According to the manufacturer, in one study evaluating rebound hypertension, the antihypertensive effect of Tekturna HCT was maintained for up to four days after the drug was discontinued, with blood pressure gradually returning to baseline. The new combination tablet will be available at wholesalers by early February and will be marketed in four strengths (aliskiren/HCTZ): 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, and 300 mg/25 mg. More information is available online at www. tekturnahct.com. AM2 PAT recalls all lots of heparin and saline flushes AM2 PAT Inc. has announced a nationwide recall of all lots of both its heparin and saline pre-filled flushes after one lot of heparin flush syringes (1003-02, Lot 070926H) was found to be contaminated with Serratia marcescens. The CDC has confirmed growth of the bacteria from several unopened syringes of the product. The syringes are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun. Facilities should cease use of the flushes immediately and return the product to their distributor. A list of all affected lot numbers can be found at www.fda.gov/medwatch/ safety/2008/safety08.htm#Heparin. Government/Law Miami defendants in strike force case sentenced for Medicare fraud Assistant Attorney General Alice S. Fisher of the Criminal Division and U.S. Attorney R. Alexander Acosta of the Southern District of Florida announced that owners of nine separate Miami-based healthcare corporations have been sentenced to prison terms within the past two weeks. Collectively, the nine defendants filed fraudulent claims with Medicare for $56.5 million worth of unnecessary durable medical equipment (DME) and infusion therapy. New estimates of VTE risk added to Ortho Evra PI Two new estimates of relative risk for venous thromboembolism (VTE) have been added to the prescribing information (PI) for contraceptive patch, Ortho Evra (norelgestromin/ethinyl estradiol transdermal system). The odds ratio from one estimate was 1.1, indicating no increase in risk for VTE and the other was 2.0, indicating twice the risk for VTE while using the patch, compared with women taking oral contraceptives. According to the manufacturer, Ortho-McNeil-Janssen Pharmaceuticals, the previous labeling also listed two estimates of relative risk for VTE: 0.9 (indicating no increase in risk) and 2.4 (an approximate doubling of risk). The new information will be presented in table format in the Warnings section of the PI and is based on results of a study conducted by the Boston Collaborative Drug Surveillance Program, involving women aged 15 to 44 years. NACDS hails bill that preserves military’s access to community pharmacies The National Association of Chain Drug Stores applauded action by the House of Representatives that will preserve access to community pharmacies for military families. The House passed HR 4986, the National Defense Authorization Act for fiscal Year 2008. Both the House and Senate previously passed a nearly identical version of the Defense Authorization Act, but that bill was vetoed by President Bush because of a provision related to the Iraqi government. The House revised that provision and re-passed the new version of the Defense Authorization Act. DT New drug approval addresses two cardiovascular risk factors Daiichi Sankyo’s Welchol (colesevelam HCl) has gained approval for a new indication. It can be used to reduce AIC in adults with Type 2 dia- http://www.drugtopics.com http://www.fda.gov/medwatch/safety/2008/safety08.htm#Heparin http://www.fda.gov/medwatch/safety/2008/safety08.htm#Heparin http://www.tekturnahct.com http://www.tekturnahct.com
Table of Contents Feed for the Digital Edition of Drug Topics - February 4, 2008 Drug Topics - February 4, 2008 Medication Errors: A Plan for Quality Can You Explain Pharmacy to an Eighth Grader? Latest News Roundup Drug Topics - February 4, 2008 Drug Topics - February 4, 2008 - Drug Topics - February 4, 2008 (Page 1) Drug Topics - February 4, 2008 - Drug Topics - February 4, 2008 (Page 2) Drug Topics - February 4, 2008 - Medication Errors: A Plan for Quality (Page 3) Drug Topics - February 4, 2008 - Can You Explain Pharmacy to an Eighth Grader? (Page 4) Drug Topics - February 4, 2008 - Latest News Roundup (Page 5) Drug Topics - February 4, 2008 - Latest News Roundup (Page 6)
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