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