During clinical trials, nine cases of each type of cancer were reported among patients taking dapagliflozin and only one of each among patients on the placebo, Medical News Today reported Friday.
An advisory panel is to meet Tuesday to consider the drug, which was developed jointly by Bristol-Myers Squibb Co. and AstraZeneca. The companies say they expect action from the FDA within the next few months.
In a report released Friday, the FDA said the drug appears to be effective at treating diabetes. In addition to the increased number of cancer cases, the FDA said dapagliflozin appeared to increase the risk of liver damage, urinary and genital infections and bone loss, and was less effective in patients with damaged kidneys.
Rosiglitazone, a diabetes drug marketed as Avandia by Glaxo Smith Kline, was linked to an increased risk of heart attacks in 2007 after it had been approved by the FDA. Avandia is still sold in the United States but increased controls are to take effect this fall.