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

Bristol-Myers recalls warfarin lots (USA)

Bristol-Myers Squibb has issued a voluntary recall of one lot of its 1,000-count bottles of Coumadin (warfarin) 5 mg tablets after the company found that one tablet had higher doses than expected. The New York City-based Bristol-Myers said the lot affected is 9H49374A and has an expiration date of September 30, 2012. The FDA said that an overabundance of the active ingredient could increase the risk of bleeding while a decrease of the active ingredient could increase the risk of clots that could increase MI or stroke. While the company said that patients on warfarin should not discontinue treatment, it recommended that patients check with their pharmacists to see if they were administered the infected lot. The FDA concluded that clinicians and patients should report any adverse events to the agency's MedWatch Safety Information and Adverse Event Reporting Program

Astra, Bristol diabetes drug wins EU approval

"A new diabetes drug from AstraZeneca and Bristol-Myers Squibb has been approved for sale in Europe, clearing the way for a head-to-head battle with Merck & Co's Januvia in EU markets. The green light for Onglyza from the European Commission had been widely expected, following a positive recommendation from the European Medicines Agency in June. The two pharmaceutical partners said they expected to launch Onglyza in Europe in the fourth quarter of 2009 as an add-on therapy for use alongside the older medicines metformin, thiazolidinedione or sulphonylurea. Both Onglyza and Januvia, which sold $1.4 billion worldwide in 2008, aim to enhance the body's ability to lower elevated blood sugar levels and are part of a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors" - Reuters