Diabetes Medications May Have Cancer Link

An FDA advisory committee will meet this week to review data from clinical trials of the Bristol-Myers Squibb and AstraZeneca  experimental diabetes drug dapagliflozin, data that has revealed an unusually high number of users who developed bladder cancer or breast cancer.  The committee of outside experts will probably issue a recommendation on the new drug application for dapagliflozin by October, and a positive recommendation could be compromised by the high rate of cancer. Although the FDA is not required to follow the recommendations of advisory committees, the agency usually does.Of 5,478 patients taking part in dapagliflozin clinical trials, nine were diagnosed with breast cancer and nine were diagnosed with bladder cancer over the two year study period, according to FDA briefing material. That compares to one case of bladder and breast cancer each among 3,156 control subjects. Additionally, data suggests that the drug is not as effective on diabetes patients with moderate or severely impaired kidney functions, and may increase the risk of urinary infections and genital infections. One case of severe liver injury was reported.Bladder cancer concerns are also swirling around Actos, the leading type 2 diabetes treatment in the world. France and Germany recently issued a recall after studies showed that the medication may increase the risk of bladder cancer. In the United States the FDA has issued an Actos bladder cancer warning and is continuing to review the safety of the drug. The Takeda drug remains widely used in the U.S.An FDA advisory committee will meet this week to review data from clinical trials of the Bristol-Myers Squibb and AstraZeneca  experimental diabetes drug dapagliflozin, data that has revealed an unusually high number of users who developed bladder cancer or breast cancer.  The committee of outside experts will probably issue a recommendation on the new drug application for dapagliflozin by October, and a positive recommendation could be compromised by the high rate of cancer. Although the FDA is not required to follow the recommendations of advisory committees, the agency usually does.Of 5,478 patients taking part in dapagliflozin clinical trials, nine were diagnosed with breast cancer and nine were diagnosed with bladder cancer over the two year study period, according to FDA briefing material. That compares to one case of bladder and breast cancer each among 3,156 control subjects. Additionally, data suggests that the drug is not as effective on diabetes patients with moderate or severely impaired kidney functions, and may increase the risk of urinary infections and genital infections. One case of severe liver injury was reported.Bladder cancer concerns are also swirling around Actos, the leading type 2 diabetes treatment in the world. France and Germany recently issued a recall after studies showed that the medication may increase the risk of bladder cancer. In the United States the FDA has issued an Actos bladder cancer warning and is continuing to review the safety of the drug. The Takeda drug remains widely used in the U.S.