Product Liability

Experimental diabetes drug may increase risk for bladder, breast cancers

The severe restrictions recently placed on Avandia because of cardiovascular risks, and new warnings that Actos may cause bladder cancer have created a vast need for safe and effective drugs to treat type 2 diabetes. Unfortunately, the outlook isn’t bright.

Dapagliflozin, an experimental diabetes drug developed by Bristol-Myers Squibb and AstraZeneca, was found to raise the risk for both bladder cancer and breast cancer, based on data from a long-term clinical program. The findings were presented in June at the American Diabetes Association Meeting in San Diego.

The study involved 5,478 patients on long-term dapagliflozin therapy, in which 9 breast cancers and 9 bladder cancers were detected, compared to 3,156 patients in the control group in which 1 breast and 1 bladder cancer were found. Researchers say it is impossible to know how many of those patients had cancer prior to the start of the trial.

Considered a novel treatment, dapagliflozin is the first insulin-independent mechanism for the treatment of diabetes. It was developed to treat both type 1 and type 2 diabetes, and was a potentially attractive alternative to other diabetes drugs because of its positive effects on insulin supply and weight loss. However, based on the new data, a Food and Drug Administration (FDA) advisory committee voted 9 to 6 that the drug should not be approved for marketing because of its potential cancer risks. The committee also raised concerns about the drug’s effects on the kidneys, especially long-term use.

The FDA is not required to follow the recommendation of its advisory committees, but it usually does.

ACTOS is a trademark 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: Cancer Network