FDA has issued a safety warning on SGLT2s titled: SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood.
Some highlights. Note the second, FDA is NOT recommending stopping use.
ISSUE: FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. FDA is continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.
RECOMMENDATION: Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines without first talking to your prescriber.
All this information at this point is conflicting and there is a lot of confusion. What is apparent is that there were 20 cases of acidosis (DKA or HHS) reported in the FDA reporting database. These were Type 2 patients and their onset of problems were also associated as having been potentially triggered by major illness, reduced food and fluid intake, and reduced insulin dose. This is 20 patients over probably millions of patient-years, so this is a fairly rare risk. And probably the best message is to stay hydrated and don’t needlessly restrict your insulin dose.
That being said there has been even further confusion related to the use of Invokana with T1. Anne Peters had been reported DKA associated with Invokana use but I’m not sure that was even reported to the FDA. Further discussion at the AACE meeting as covered by Close Concerns highlighted a bunch of discussion about DKA and Invokana. But strangely the discussion was entirely focused on Type 1 and never even mentioned problems with Type 2. So all I can say is things are confused.
I’m still on Invokana and I have had good success with it. I’m just going to stay hydrated.
These are such nasty drugs that it is best to err on the side of caution. The FDA delayed approval over significant cancer concerns. I didn’t see anything that suggested these concerns have been laid to rest. The FDA rarely if ever suggests a drug should be taken off the market even when very significant problems are reported and carefully documented. The people making decisions at th FDA go back to Big Pharma when they leave the agency and don’t want to be tagged “the guy who killed the golden goose.”
I think it is quite possible that these drugs could be raising the risk of severe blood imbalances because they change the way that the kidney filters things. We know that the drug companies are not required to study in great detail how their drugs affect anything except the factor they set out to modify (blood sugar in this case.) As long as they don’t cause a lot of cancer very fast or kill a lot of people very fast, the unintended consequences of their action take a decade or more to emerge.
In this case, the emergence is pretty fast. And considering that many people take these drugs with metformin, which can also be dangerous in a compromised kidney, even more caution is required.
It’s not like these drugs provide significant benefit or even improve insulin resistance. They just make it much easier to get urinary tract infections, which would be enough to keep me from every taking one, having been through pure hell with UTIs in the past.
I was at the FDA hearings for a number of these. There was extensive data presented, specifically about cancer risks. FDA had an oncology specialist on the review team.
The risk was not characterized by anyone as significant. As I recall, and I didn’t take notes and it was a few years ago, it was talked about as a possible signal in the data or as possibly an insignificant variance. As I recall the incidence of cancer were in individuals with other significant cancer risks, the cancers term of growth was longer term and unlikely to have been caused in the sort term of the trial. In all cases ongoing post market evaluations of cancer impact was required.
What was clear was SGLT2 may help some people but not all. I am all for more options for individuals to consider with their physicians. I don’t discount that they suck for some and help others. Your Diabetes May Vary
Considering there was NO cancer signal noticed from Actos for years and now they are paying out big settlements for that, any early signal pointing to cancer should be heeded.
The FDA committees that reviewed these drugs were not enthusiastic about them. There was also that strong signal in the studies of more strokes occuring shortly after starting the drugs.
If they made a huge difference, perhaps they might be worth trying, but they don’t. Insulin is a better choice for people who have deteriorated on the other orals.
These drugs are much more about repairing the health of big pharma income than of PWD.
