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jq1234

06/27/11 12:20 AM

#122394 RE: DewDiligence #122392

There maybe many different explanations for the imbalance, but the drug could also accelerate bladder cancer development, I don't think you can exclude it at this point. I think regulators are going to be very careful with bladder cancer risk because of mechanism of action. At minimum, large post marketing studies will be required:

Patients on dapagliflozin were more likely to have urinary tract and genital infections than those taking glipizide, the study showed. Excess sugar in dapagliflozin patients’ urine makes it easier for bacteria to grow, causing infections, said Rita Rastogi Kalyani, an assistant professor of medicine at Johns Hopkins University in Baltimore. Most of the infections happened in the first year of the study, the data showed.



Personally I think it should be approved, and actos should stay on the market because diabetes drugs are going to have some risk. People have to accept some types of risk for these types of drugs - doctors and patients should be aware of the risks and manage the risks themselves.