NN&I - June 2010

Diabetes Watch 24 Nephrology News & Issues June 2010Subscribe to our free eNewsletter at www.nephronline.com After 710 deaths and 87 product recalls, FDA tightens scrutiny of drug pumpsAfter more than 50,000 reports of prob-lems with pumps used to deliver drugs, including 710 deaths, the U.S. Food and Drug Administration will begin more rigorous pre-market review of the devices, one of the agency's center directors said April 23. "There have been problems with every kind of infusion pump on the market, across the entire industry," FDA Center for Devices and Radiological Health director Jeffrey Shuren, MD, told the annual meeting of the Association of Health Care Journalists. The devices are used by millions of people to deliver insulin for diabetes, antibiotics for infections, chemother-apy for cancer, and pain medication, among other drugs. One of the 710 deaths was a woman who died after receiving 10 times the dose of a blood thinner because the zero key on her pump stuck. Other devices have caught fire and exploded in patients' rooms, Shuren said. Of the 87 product recalls, 14 were of the FDA's highest-risk category, meaning there was "a reasonable prob-ability that using the device will cause serious injury or death." Those recalls ranked "among the top most frequent-ly recalled devices in that period," Shuren said.More than 100 companies make infu-Pharma's marketGenetic mutations may cause type 1In a study supported by the National Institutes of Health that appeared in the May issue of the Journal of Clinical Investigation, scientists from the Scripps Research Institute resolved a 40-year-old mys-tery of how three genetic varia-tions located in the region of the genome called HLA, human leuko-cyte antigen, are known to dramati- cally increase risk of developing type 1 diabetes. High-heated food may cause type 2 According to study in the May issue of the American Journal of Clinical Nutrition, French research- ers found that a diet based on high- heat-treated foods increases mark-ers associated with an enhanced risk of type 2 diabetes and cardiovascular diseases in healthy people.sion pumps, Shuren said, with Baxter International and Hospira two of the major manufacturers.The new initiative will require pump manufacturers to include more infor- mation about their design. The FDA said it will also offer manufacturers "the option of submitting the software code used in their infusion pumps for analy-sis by agency experts prior to premarket review of new or modified devices, in order to facilitate the early detection and correction of any design defects."The agency will also launch a web-site for patients to learn more about the devices and to allow patients to report problems. Victoza trumps Januvia in reducing blood sugar Daily injections of both high- and low doses of Novo Nordisk's new diabetes drug Victoza proved more effective than Merck & Co's daily tablet of Januvia in a head-to-head study, researchers reported in the UK journal The Lancet on April 23, boosting prospects for a product that has got off to a strong start in key markets. Phase 3 trial for lixisenatide successful A final-stage study of Paris-based Sanofi-Aventis's type 2 diabetes drug lix-isenatide was successful, the company said April 15, adding that the once-daily doses of the drug improved glycemic control in patients and reduced glucose in blood cells. The results gave the drug maker new ammunition in the growing but competitive diabetes market. One small step for MannKind's inhaled insulin device Afrezza MannKind Corp. said April 23 that its experimental, rapid-acting inhaled insu-lin device, Afrezza, controls blood sugar levels in patients with diabetes better than injectable products without meaningful, long-term changes in lung function. Results from two Afrezza Phase 3 studies were presented in Boston at a meeting of the American Association of Clinical Endocrinologists. Final straw for Avandia? U.S. regulators are considering ending a safety study on GlaxoSmithKline's dia-betes drug Avandia, The Wall Street Journal reported April 18, a move that could jeopardize the drug's presence in the U.S. market. Victoza trumps Januvia in reducing blood sugar Daily injections of both high- and low doses of Novo Under study In a study supported Under study Diabetes_NNI0610_5.indd 24 5/14/10 3:08:33 PM