FDA rejects type 2 diabetes drug based on bladder, breast cancer risks

The Food and Drug Administration (FDA) has rejected the experimental type 2 diabetes drug Dapagliflozin because it poses a risk for bladder and breast cancers. Drug makers Bristol-Myers Squibb and AstraZeneca must provide more data on the drug’s risks and benefits before the FDA would be willing to consider approving the drug for use in the United States.

Dapagliflozin works by increasing renal glucose elimination, thereby allowing more sugar to be excreted in the urine. An FDA advisory panel voted in July to recommend the approval for the drug, but raised concerns over the cancer risks that rose out of phase III clinical trials.

Nine bladder cancer cases were reported in the 5,478 patients on the drug compared to one case in the 3,156 patients who took a placebo. There were also nine cases of breast cancer in the 2,223 women who used the drug compared to one in the 1,053 women in the control group.

One FDA reviewer noted that women who took Dapagliflozin had a fourfold increased risk of developing breast cancer compared with those who did not take the drug; and that men who took the drug had five times the risk of developing bladder cancer compared to those who didn’t take the medication.

The FDA is likely exercising more caution with type 2 diabetes drugs, especially when it comes to reports of serious injury. Last year, the agency issued a safety notification to doctors and patients that the type 2 diabetes drug Actos increased the risk for bladder cancer. This news came just months after drug regulators severely restricted the use of the type 2 diabetes drug Avandia for allegedly causing deadly heart attacks.

ACTOS, ACTOplus met, ACTOplus met XR, and duetact are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

AVANDIA is a registered trademark of GlaxoSmithKline.

Source: MedPageToday