Invokana causing risk of lower limb amputation, FDA warning


#1

Is this report reliable:
Excerpt from the report:
[ 5-16-2017 ] Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
Website source:
https://www.fda.gov/Drugs/DrugSafety/ucm557507.htm


#2

Sounds scary. I’ve seen a few negative posts on the side effects of Invokana. Seems like a drug you’d only want to use if nothing else was working.

Looks like the likelihood of amputation doubles:

"The CANVAS trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:

5.9 out of every 1,000 patients treated with canagliflozin
2.8 out of every 1,000 patients treated with placebo

The CANVAS-R trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:

7.5 out of every 1,000 patients treated with canagliflozin
4.2 out of every 1,000 patients treated with placebo"

The article is on the FDA website. I’d call it pretty legit since it’s referencing specific studies and direct conclusions.

Here’s a thread that discusses this problem: Invokana Amputation


#3

I was able to go into ketosis with invokana and lose 22 lb. Magical. Yes of course everything you do involves risk. Thanks for posting.


#4

The placebo result for me is very worrisome.
How is this explained?


#5

And despite this FDA warning, Doctors still prescribe Invokana. Can Doctors be sued along with the Invokana manufacturer? I have seen a few Lawyers’ firms advertising to help Invokana amputees.


#6

I believe that means those patients (on placebo) used no method of controlling their diabetes, but I could be wrong. I’m not entirely sure how that would be comparable to those on Invokana because it seems like their A1c and control would be drastically different. You’d think there would be more amputations in the placebo group due to poor control!! I’d have to look into it more to figure that out.

I think the evidence is pretty conclusive though. There is a higher risk of amputations with Invokana. I’m not sure why it is still on the market. This is not a drug I would be willing to take. There are plenty of others out there I’d try first. I’d also go on insulin as a T2 before taking this.


#7

Hi @Calgarydiabetic! I’m glad you’ve been able to lose some weight!

Do you think you might reconsider Invokana given this study? It’s very worrying!

I don’t think it’s necessary to be on Invokana to go into ketosis. For most people, it is possible with diet alone. I have a friend on the ketogenic diet. He eats high fat/low carb foods, limiting carbs to 25-30 grams a day. He’s been in ketosis for months without being on any medications.

Here’s a table showing a more detailed breakdown:


#8

I keep on saying this to type 2s. When I was diagnosed by my GP, I asked him to put me on insulin, and he said I was borderline and he can still pump more pills on me. My A1c then was 7.9… I told him it should be close to normal 5… 10 pillls a day and one year later, exercise and diet, the A1C did not change. He then sent me to an endo who then put me on more pills. I suspect they get kick-backs from pharmas. Pills are more expensive than insulin here in Canada. I don’t trust doctors. But luckily after firing the bad ones, I have now great GP and Endo who write me scripts that I tell them to give me. When I feel I need a change in my regimen, I do my research, print it out, show my doctor for the new scripts. I call the SHOTS with my diabetes. Pun intended. LOL.


#9

No I need the invokana because of extreme insulin resistance . Without invokana I need over 100 units/day of insulin. this is enough to inhibit any fat burning and typically my BHB was below 0.2 mmol/L with invokana I was able to cut insulin to a mere 30 u/day and BHB was in a nice range of 1.5 to 3.5 mmol/L. Sure if you are not injecting insulin the cutting the carbs in your diet will cut the insulin your body produces.

Yes I will try invokana again sometimes in the future do not see any other way to lose body fat. I am open to alternatives ?


#10

Here’s a thread that discusses another SGLT2 inhibitor, Jardiance: Type 1 and new drug Jardiance. Invokana comes up a couple times though. It sounds like dehydration may be a contributor to the amputation risk. Not sure about that though.

Jardiance and Farxiga are in the same class of drugs as Invokana (SGLT2 inhibitors), so they may provide the same benefits. Here’s an article that discusses how other meds in this class aren’t showing as elevated of levels of ampuation: https://www.medscape.com/viewarticle/883782.

These may have other side effects though. Everyone is different, so maybe Invokana works better than these other drugs for you. Jardiance is supposed to be good for your heart though, so if you have any cardiovascular problems, that might be a good drug to consider.

Stay hydrated :slight_smile:


#11

Can you please explain what BHB is? Is it A1c?


#12

I think it’s a way of determining if you’re in ketosis: https://www.ekfdiagnostics.com/beta-hydroxybutyrate.html


#13

Thanks, @katers87. So it’s beta-hydroxy-buterate. I didn’t know that you could test for BHB, a precursor to ketone bodies. When I first started eating low-carb high-fat, I would test my blood ketones with a home meter. It was fun getting the confirmation that I was in nutritional ketosis but the strips were very expensive.


#14

Another bad news about Invokana. Can cause kidney cancer.

From the site:
https://www.ehealthme.com/ds/invokana/kidney-cancer/


#15

Hydration no kidding I was drinking nearly 6 L of water /day. this is very important to drink a lot wonder if amputees forgot this little fact. Also electrolytes.

Yes I was thinking of trying another one in the same class. Invokana is covered by my insurance. I would not take it if I was female from the plumbing point of view. I was peeing out up to 150 grams of glucose/day. This is heaven for yeast.


#16

It is beta hydroxy butyrate. It is equally as good as glucose in turning ADP into ATP which is the fundamental molecule that provides energy to the cells. You can get freestyle tests strips that measure BHB in the blood. This is the only way to fly since ketones in the urine are meaningless. From the diet point of view I suppose they are of some use to detect DKA but again there blood test strips way better.