FDA MedWatch Safety Alerts http://www.fda.gov/medwatch en-us Fri, 03 Oct 2008 16:10:00 EDT jay.wattenberg@fda.hhs.gov Healthcare professionals, consumers Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Fri, 03 Oct 2008 16:10:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Nebion http://www.fda.gov/medwatch/safety/2008/safety08.htm#Nebion Surgical healthcare professionals, hospital surgical service managers Class I Recall because of potential misconnections of the Medtronic sutureless connector catheters from the catheter port on the pump. Thu, 02 Oct 2008 10:50:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#INDURA http://www.fda.gov/medwatch/safety/2008/safety08.htm#INDURA Healthcare Professionals Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Wed, 01 Oct 2008 17:55:00 EDT http://www.fda.gov/psn http://www.fda.gov/psn Neurologists, cardiologists, consumers New analysis of 41 long-term controlled clinical trials provides evidence that use of statins does not increase incidence of ALS. Tue, 30 Sep 2008 11:00:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Statin http://www.fda.gov/medwatch/safety/2008/safety08.htm#Statin Oncologists, hematologists Preliminary safety findings from a German clinical trial showed more deaths in patients given epoetin-alpha versus placebo. Fri, 26 Sep 2008 11:10:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA3 http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA3 Hospital ER and ICU medical and nursing personnel, risk managers Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. Tue, 23 Sep 2008 14:35:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ammonul http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ammonul Oncological healthcare professionals Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Tue, 23 Sep 2008 14:35:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tarceva http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tarceva Consumers, pediatricians, other healthcare professionals UPDATE - FDA investigation of Asian markets found no Chinese-manufactured infant formula on shelves. Mon, 22 Sep 2008 11:25:00 EDT http://www.fda.gov/medwatch/safety/2008/safety08.htm#formulaChina http://www.fda.gov/medwatch/safety/2008/safety08.htm#formulaChina Healthcare professionals Summer 2008 edition available for healthcare professionals and the medical community. Thu, 18 Sep 2008 15:22:00 EDT http://www.fda.gov/cder/dsn/2008_summer/toc.htm http://www.fda.gov/cder/dsn/2008_summer/toc.htm