Is the new diabetes drug Dapagliflozon safe and effective?

On June 24, 2011, Bloomberg reports that the BMS and AZ diabetes drug, dapagliflozon, is safe and effective based on a study comparing the drug with metformin against metformin+glipizide. The article did acknowledge that dapagliflozon was associated with more urinary and genital infections.

On June 27, 2011, Yahoo health reports that dapagliflozon is effective but in addition to patients having more infections, it seems that an increase in bladder and breast cancer may also be associated with the drug.

Dapagliflozon is in a new class of drugs that blocks glucose from being absorbed into the bloodstream through the kidneys and allowing more sugar to be released in the urine. Therefore, sugar spends more time in the urinary tract, which could explain the increases in infections as bacteria would have more time to grow. Diabetes patients are already at increased risks for these types of infections so this drug increases that risk even more.

However, cancer increases should be met with some concern. Actos is also being linked to increases in bladder cancer by those who take it more than a year. Januvia and other DPP-IV drugs are linked to suppressing the body's able to fight cancer. As most patients diagnosed with diabetes remain on some medication for perhaps the rest of their lives, the increased cancer risks are serious.

And the label will already carry the risk for renal impairment or failure which would make sense as the kidneys would have to work harder on this drug.

That is not to say that the drug doesn't do some good things. It can lower blood pressure and seems to help patients make it easier to lose weight. Patients only need to take it once a day. These are real positives.

Lilly, J&J, Boehringer Ingelheim, and Astellas are all developing drugs in this new class. So, the risk-benefit profile needs to be carefully watched. If in a two year study the cancer and infection rates are already significant, what happens after 10 years.

The Bloomberg article reports that physicians will begin using the drug immediately upon approval. The FDA is scheduled their review for July 19.

If I were a patient and I looked at this data, I'm not sure I would be ready to take it so fast.

It is rare in the data we have (and we have an enormouse amount of diabetes data), do I see phyicians and patients talking about that patient's personal risks before taking a drug. So for example, for dapagliflozon, I would think it wise to find out if the patient already had frequent URI or genital infections, compromised kidneys and/or if there is a family history of certain cancers. To me, immediately if any of these things were true, then the patient would not be a candidate for this drug or any in its class. That way, perhaps this drug can be useful and valuable while mitigating the risks in the wrong patients.

However, since we do not see this happening much today, I am not convinced it will happen with this drug either. Therefore, my prediction is that is the FDA approves the drug, we will see serious problems reported by patients within 2 or 3 years post approval that perhaps could have been avoided.