Friday, July 15, 2011

FDA cites higher cancer rate with diabetes drug from Bristol-Myers, AstraZeneca

Federal health regulators have concerns about bladder and breast cancer seen in patients taking an experimental diabetes pill from Bristol-Myers Squibb and AstraZeneca. The Food and Drug Administration said in an online review Friday that there were more cases of cancer among patients taking the company's drug than those taking a dummy pill. It was not clear whether the higher rate was caused by a statistical fluke or the drug itself. A panel of FDA advisers meets next Tuesday to discuss the drug's safety and effectiveness. Along with cancer, the FDA will also ask the panel to comment on the drug's effects on kidney and liver function. FDA will make the final decision on the drug's approval. Dapagliflozin is a once-a-day pill designed to help type 2 diabetes patients eliminate excess sugar in their urine. It differs from older drugs that decrease the amount of sugar absorbed from food. If approved, Bristol and AstraZeneca's drug would be a new option for diabetics, who must often rotate through several medications to control their disease - AP

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