Are SGLT2’s next on the hit list?
Yesterday Dr. Gary Pepper, a leading endocrinologist with 39 years of experience, penned a piece for Metabolism entitled “New Diabetes Medications Give Early Indication of Danger”. In this piece Dr. Pepper states;
“I am not surprised that these drugs can cause DKA but I am more concerned about the potential they could cause other complications harder to recognize. In the early stages of type 2 diabetes, oral medications will help control blood sugar and slow development of diabetic complications. Over time the oral medications become less effective as the ability of the body to make insulin deteriorates. At some point it is highly likely that the pills will stop working all together and insulin treatment is required to prevent dangerously high glucose levels from developing leading to serious dehydration. If left untreated, a life threatening condition, hyperosmolar coma develops. My concern is that a person on pills for diabetes who is in the early stage of diabetic “burnout” may be given an SGLT2 drug. Weight loss is a warning sign of an impending hyperosmolar state but can also be an indication that the SGLT2 pill is working. It will be easy to mistake the weight loss as a good sign even though the medication is actually making the situation worse by accelerating dehydration, promoting the rapid emergence of the “hyperosmolar” state. A hyperosmolar state is harder to recognize than DKA but can be just as deadly. The population susceptible to hyperosmolar state is likely to be extremely large, larger than those who develop DKA. Expect it to take longer to recognize this as a complication of SGLT2 drugs due to confusion as to the cause and potential corporate foot dragging.”
He concludes by stating; “I strongly urge that SGLT2 inhibitor drugs receive immediate review for potential unrecognized dangers such as hyperosmolar diabetic state and DKA. Professional guidelines should be immediately revised to take into account potential serious consequences of using these medications.”
Now Diabetic Investor does not want to be overly melodramatic here but we have been down this road before. Given that SGLT2’s have only been on the market for a relatively short period of time Dr. Pepper did not cite any meta-analysis as our good friend that crusading cardiologist Dr. Steven Nissen did with Avandia. However given the growing popularity of SGLT2’s we wouldn’t be surprised if his concerns draw the FDA’s attention. Already the FDA has issued a warning on these drugs due to concerns with DKA. It’s not difficult to imagine a scenario where the agency takes another at this category especially if other respected researchers jump on Dr. Pepper’s bandwagon.
Keep in mind that it took nearly 7 years to discover that TZD’s were linked to an increased incidence of bone fractures. Also keep in mind the FDA mainly due to the Avandia controversy has become ultra-sensitive to any adverse events related to diabetes medications. Should this issue gain momentum Diabetic Investor suspects the agency won’t hesitate and take more action.
At this point we should note that Dr. Pepper did not disclose any possible conflicts of interest so it’s difficult to gauge whether he is just a concerned physician or whether he has a different agenda in mind. But in today’s world this lack of disclosure and possible agenda’s almost don’t matter. It’s just a matter of time and technology before his concerns reach a broader audience including class action attorneys who just love suing big pharma. This unfortunately is the world we live in.
Anyone who looks back at the Avandia controversy understands that when it comes to diabetes medications and possible adverse events real hard evidence is not needed to prove a point. That a drug can be guilty in the eyes of patients and physicians without data backing up a claim. And as we witnessed with Avandia even when there is data it can interrupted with widely different conclusions. Again this is the world we live in.
One lesson that should have been learned from the Avandia controversy is that once in the public domain issues over a drug can take on a life of their own. That by the time real evidence comes to light it’s often too late as the damage has already been inflicted. Our concern here is the same as it was with Avandia the impact this news will have on patients and their physicians. Physicians who are finding it increasingly difficult to answer what seems like a very simple question they get from patients all the time; “Is the medication I’m taking safe?”
Again we don’t want to be overly melodramatic but unfortunately we also have been around awhile and have seen this situation before. As Norman Cousins once noted; “History is a vast early warning system.”