Breast Cancer Linked To New Diabetes Drug, FDA Says
Breast cancer and bladder cancer have been linked to a diabetes drug that is currently under development, the U.S. Food and Drug Administration says.
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, reports Medical News Today.
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.
The drug was less effective in treating patients with damaged kidneys, Medical News Today reports.
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.
The panel of outside experts will likely issue a recommendation on the new drug application for dapagliflozin by October, which could be endangered by the high rate of cancer.
Although the FDA is not required to follow the recommendations of its advisory committees, the agency usually does, About Lawsuits reports.