A potential new treatment for type 2 diabetes, dapagliflozin, recently failed to gain approval from the FDA. What makes this rejection noteworthy is that the new medication works by a completely new mechanism causing the kidney to excrete sugar from the blood into the urine. Reasons for the rejection were the increased risk of bladde and breast cancer in those taking the medication, increased urine and genital infections and possible liver toxicity. That list of problems seems pretty convincing to me. This is unfortunate because the drug appears to cause weight loss and does not cause low blood sugar (hypoglycemia). However, a drug that works by “poisoning” the kidney so that it dumps sugar into the urine strikes me as a drug that is going to cause a lot of other problems.
The other established diabetes medication generating new warnings is Actos (pioglitazone). I have written a number of articles on the sister drug Avandia, defending its usefulness despite possible cardiovascular risks, but the cancer warning for Actos is a new angle on this class of drugs (thiazolidinediones). Actos has been withdrawn in France due to concerns that it may cause bladder cancer but no such action has been taken in the U.S. The FDA this month did issue a warning that individuals with bladder cancer or at risk for bladder cancer, should be advised not to use Actos. If Actos is hit hard by these actions this whole class of diabetes drugs will have been eliminated from use.
A sure sign of trouble for Actos is that a “google search” for Actos is now showing lawyer websites as the first 5 citations.
Being sick is dangerous. Treating illness also has dangers. I am concerned that our cultural zeal for uncovering scandals and for pursuing litigation will lead us to sterile treatment options and doctors who are unwilling to risk helping.
Gary Pepper, M.D.
Editor in Chief, metabolism.com