Documents released ahead of a FDA panel meeting to evaluate new diabetes drug dapagliflozin, suggest concerns over its adverse effect profile.

There has been at least one case of dapagliflozin-induced liver injury and 9 women (0.4%) developed breast cancer compared with 1 woman, (0.09%) in the control group. For bladder cancer, the rate was 9 cases (0.3%) on dapagliflozin compared with 1 case (0.05%) in the control group. B-MS and AstraZeneca claim that when all types of cancer, not just breast and bladder, are considered, there is no increased risk with their drug. In addition, some of the cancers were diagnosed so soon after the start of the trials that causality cannot be established.

There are also concerns about genital-urinary infections associated with dapagliflozin therapy, bone safety and the claim that the drug is not effective in patients with moderate to severe kidney impairment.

Dapagliflozin is the first drug in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, that are designed to block the absorption of glucose and thus increase its urinary excretion.