Drug Topics July 7, 2008 - (Page 6) 6 DRUG TOPICS JULY 7, 2008 www.drugtopics.com > > >NEWS Roundup Rx Care against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Those companies and individuals warned, the complete list of fake cancer 'cure' products and their manufacturers, along with a consumer article on health scams can be found on FDA’s Web site. New boxed warning required for antipsychotic label The Food & Drug Administration has issued letters to manufacturers of all antipsychotics requiring a new boxed warning of an increased risk of death in elderly patients with dementia. While the atypical antipsychotics have had a similar boxed warning included in their labels since 2005, data showing an increased mortality risk with use of conventional antipsychotics were not available until now. Results from two new observational studies did show an increased risk of death associated with their use. While the agency admits the new studies are not ideal and do possess limitations, the FDA thought the data are strong enough to warrant the label revision nonetheless. Manufacturers of the drugs will have 30 days to submit new language to the FDA for review, or face enforcement action under new authority granted to the agency under FDAAA—the Food and Drug Administration Amendments Act of 2007. Professional Practice Iowa flooding not dampening Iowa Pharmacy Association's plans The recent flooding in the Midwest has not negatively affected Iowa pharmacies, according to an Iowa Pharmacy Association spokeswoman. "We're doing fine here. It left as fast as it came. We're going to have our Golf Tournament on Friday at Willow Creek. The Marriott downtown had no damage. All of the bridges are open. All of the major roads that were closed are open. We haven't heard of anything terrible from our pharmacies," she said. Cymbalta gets nod for fibromyalgia Results from two three-month clinical trials involving 874 patients with fibromyalgia have led to a new Food & Drug Administration approval for duloxetine (Cymbalta, Eli Lilly). The serotonin-norepinephrine reuptake inhibitor has been shown to reduce pain in patients with the disorder—51% and 55% of patients taking duloxetine in each study experienced a 30% improvement in the Brief Pain Inventory (BPI) 24-hour average pain scale. In addition, 65% and 66% of patients taking the drug reported feeling better since the beginning of treatment as measured by the Patient Global Impression of Improvement. Duloxetine was previously approved by the FDA for the treatment of diabetic peripheral neuropathic pain, major depression, and generalized anxiety disorder in adults. Joint Commission issues 2009 National Patient Safety Goals for hospitals The Joint Commission’s 2009 National Patient Safety Goals have several requirements that pertain to pharmacy. For instance, hospitals must implement practices to prevent hospital-acquired infections due to multiple drug-resistant organisms. This requirement takes effect on Jan. 1, 2010. Other changes involve revisions to the medication reconciliation and anticoagulation standards. Managed Care Humana loosens its drug refill rules following natural disasters In view of the storms, tornadoes, and/or flooding that have wreaked havoc in many states over the past few days, Humana said it is allowing early prescription refills for its affected members through June 22. Areas covered include: • 55 counties in Iowa, • 30 counties in Wisconsin, • six counties in Illinois, and • two counties in Minnesota. In addition, the same holds true for two counties in Northern California, which have been devastated by wildfires. Members with questions can call the toll-free number listed on the back of their Humana ID cards. Requip XL receives FDA green light GlaxoSmithKline (GSK) has announced the Food & Drug Administration approval of ropinirole extendedrelease tablets (Requip XL) for the once-daily treatment of Parkinson’s disease. Efficacy of the new tablet was proven in the EASE-PD Adjunct study of 393 patients who received treatment with l-dopa plus either the new product or placebo. Results showed Requip XL significantly reduced “off” time by an average of 2.1 hours per day compared with 0.4 hours for placebo. The immediate-release version of ropinirole (Requip, GSK) is indicated for the treatment of restless legs syndrome. http://www.drugtopics.com http://www.fda.gov/cder/news/fakecancercures.htm http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/09_hap_npsgs.htm http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/09_hap_npsgs.htm http://www.humana.com
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