Three new Type II diabetes drugs on the market clearly have serious safety problems. They can cause an uptick of dangerous blood acids called ketones, as I’ll explain more in a moment.
The FDA has been studying this problem for years. And it finally acted.
Well, sort of.
Last month, they issued a “warning.”
I’ve been “warning” you about these drugs for years. In fact, I often wonder how I stay so far ahead of the FDA, time after time. Well, I guess you can think of me as your “early warning system.”
As a radar engineer, my father worked on the government’s distant early warning (DEW) systems with NATO during the 1950s and 1960s. The government set it up to detect the approach of bombers or missiles from the former Soviet Union while there still might be time to do something about it. When I was an officer-in-training in the Air Force during the early 1970s, we studied all about the DEW Line as part of NORAD (North American Air Defense) capability.
But it seems the FDA’s “dew line” is all wet.
If we wait for the FDA to make a decision, take a position, and issue a “warning,” it’s already too late. And if FDA ran the Department of Defense back in the ‘50s and ‘60s, you wouldn’t have known about those Soviet bombers until they dropped into your home for dinner.
In my Daily Dispatch and Insiders’ Cures newsletter, I issue all my warnings well in advance and in plain English. (I like to think I use well-written English compared to many other internet sources.)
Now back to the new Type II diabetes drugs…
The FDA needs to focus equally on efficacy (that a treatment works) and safety (that it does not cause harm). Unfortunately, the FDA no longer has a good record in this regard.
My colleague Dr. Donald Light–formerly at Penn and now at Harvard–published a disturbing analysis about drug safety in 2013. It showed only 10 percent of new drugs approved by the FDA in the past 30 years are more effective than the drugs they would potentially replace. Plus, 50 percent of the newly approved drugs have a worse safety profile than the older drugs. In other words, they’re more dangerous than the older drugs.
The three new Type II diabetes drugs perfectly illustrate this point…
-Farxiga (dapagliflozin) by AstraZeneca
-Invokana (canagliflozin) by Johnson & Johnson
-Jardiance (embagliflozin) from Lilly and Boehringer Ingelheim
These drugs are “SGLT2 inhibitors.” They work by causing the body to excrete blood sugar through the urine. I have to wonder about the long-term consequences of exposing the kidney’s delicate urinary filtration equipment to all that extra sugar.
Plus, as I mentioned earlier, these drugs can lead to ketoacidosis, a serious condition where the body produces high levels of dangerous blood acids called ketones. This same condition is actually a component of the most dangerous, potentially fatal, complications of untreated diabetes.
Doctors do everything in their power to help diabetic patients avoid this condition. So, ironically, these new drugs can end up causing one of the most dangerous and feared complications of untreated diabetes! Plus, who knows what these drugs do to the kidneys when they’re exposed to high levels of sugars.
The FDA said all these side-affected patients required emergency room visits or hospitalization to treat the condition. How ironic. These patients taking flashy, new drugs wind up in the very same place as patients who have uncontrolled diabetes…the hospital.
Experts say the new FDA warning could help boost sales of another new Type II drug, Merck’s Januvia, which operates by a different mechanism. Januvia, which had sales of about $6 billion in 2014, is Merck’s top-selling product. But as I told you in 2013, Januvia is twice as likely to cause hospitalization for acute pancreatitis when compared to older drugs.
Why does anyone take any of these dangerous, new, and unproven drugs in the first place? Furthermore, why does any doctor recommend them?
We have a safe, effective, and affordable oral treatment for Type II diabetes that tens of millions of people around the world have safely taken for decades.
Of course, I’m talking about metformin.
Metformin originally derived from the ancient European folk remedy called French lilac. And its major “side effects” appear to be markedly lowering the risk of cancer and probably protecting against brain and neurological diseases. (One caveat is that metformin can cause some people to lose vitamin B12. So always supplement daily with a good B vitamin complex, which is good advice in any case, for diabetics and for everyone.)
As I’ve said before, in terms of safety and effectiveness profiles, there is virtually no reason to take any drug other than metformin for high blood sugar. If your doctor recommends a different medication, ask why. Unless there is a very specific reason you should be taking a different drug, ask if you can try metformin first, or switch.