Drug Topics - April 28, 2008 - (Page 7) 7 NEWS Roundup <<< transdermal system) due to the formation of crystals in the patches. According to the company, when crystals form, there is less drug available to be absorbed and efficacy of the product may be affected. Patients must first be gradually down-titrated from the patch (their dose reduced by 2 mg/24 hours with a dose reduction every other day). Patients should not abruptly discontinue therapy due to the possibility of a neuroleptic malignant syndrome or akinetic crisis that can occur with abrupt withdrawal of dopamine agonists. Following the recall, rotigotine patches will no longer be available in the United States. UCB Medical Information can be reached at 1-(800)-477-7877. findings. In October 2007, Pfizer decided to stop marketing Exubera due to poor sales; however, patients enrolled in clinical trials or extended transition programs continued to use the inhaler. Practitioners should now seek alternative treatment options to maintain blood glucose. Orencia gets FDA nod for pediatrics Children ages six years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) may now get some relief from using abatacept (Orencia, Bristol-Myers Squibb). The biologic was re- Rx Care PML in CellCept users leads to early warning The Food & Drug Administration has issued an Early Communication about the possible development of progressive multifocal leukoencephalopathy (PML) in patients taking mycophenolate mofetil (CellCept, Roche) and mycophenolic acid (Myfortic, Novartis). Roche provided safety data to the agency that show that PML is a rare complication of therapy and recommended adding the new information to the product’s label. The FDA has since requested any similar data from Novartis on Myfortic before it begins its twomonth review of the safety data and proposed revised labeling for the products. Healthcare professionals should notify the agency of any problems with these products by reporting directly to MedWatch. Currently, the FDA is not recommending any changes in how patients use these medications. cently approved by the Food & Drug Administration for this new indication following evaluation of results from the AWAKEN study, which evaluated the efficacy and safety of the therapy in this age group. The threepart trial showed that patients treated with abatacept experienced significantly fewer disease flares compared with placebo-treated patients (20% vs. 53%; p<0.001). In addition, the risk of disease flare among patients continuing on abatacept therapy was less than onethird that for patients who withdrew from treatment with the biologic. Lung cancer reported in Exubera-treated patients Pfizer has issued letters to both healthcare professionals and patients to inform them of six reported cases of newly diagnosed primary lung malignancy during clinical trials in patients using their insulin human [rDNA origin] inhalation powder (Exubera). There has also been one reported postmarketing case of lung cancer; all cases occurred in patients who were former cigarette smokers. Pfizer will also revise the Warnings section of the product’s prescribing information accordingly. At present, there are too few reported cases of lung cancer to determine whether the development of malignancies is related to the inhaled insulin, according to Pfizer. Nektar Therapeutics, maker of the device and inhalation powder used with Exubera, has ceased all negotiations with potential partners for its inhaled insulin programs in light of these new Insurers limit insulin pump coverage Coverage for insulin pump therapy, also called continuous subcutaneous insulin infusion (CSII), requires certain criteria to be met in order for insurance companies to foot the bill. According to Skip Freedman, the executive medical director at AllMed Healthcare Management, an independent review organization, pumps can benefit diabetics but only when patients understand how to use them appropriately. Freedman said that most health insurers and third-party payers will reimburse for an insulin pump if the patient is not meeting glycemic control goals and he/she has Type 1 diabetes, is under the care of an endocrinologist who manages patients on pumps, is receiving at least four injections of insulin per day, and is monitoring blood glucose at least four times a day. Patients should also complete an education program on pump operation and carbohydrate counting. DT
Table of Contents Feed for the Digital Edition of Drug Topics - April 28, 2008 Drug Topics - April 28, 2008 Contents Comparing Treatments for Effectiveness Gaining Support in Washington Pharmacogenetics: Pharmacists Should Own It, Not Fear It Cardinal Health Offers Strategies to Improve Patient Safety Latest News Roundup Drug Topics - April 28, 2008 Drug Topics - April 28, 2008 - Contents (Page 1) Drug Topics - April 28, 2008 - Contents (Page 2) Drug Topics - April 28, 2008 - Comparing Treatments for Effectiveness Gaining Support in Washington (Page 3) Drug Topics - April 28, 2008 - Pharmacogenetics: Pharmacists Should Own It, Not Fear It (Page 4) Drug Topics - April 28, 2008 - Cardinal Health Offers Strategies to Improve Patient Safety (Page 5) Drug Topics - April 28, 2008 - Latest News Roundup (Page 6) Drug Topics - April 28, 2008 - Latest News Roundup (Page 7)
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