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  #1   ^
Old Tue, May-16-17, 21:37
JLx's Avatar
JLx JLx is offline
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Plan: IF
Stats: 210/191/165 Female 66
BF:High wt, 276, 255
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Location: Michigan U.P., USA
Default FDA warns of foot, leg amputations with J&J diabetes drug

What an incredible headline! Isn't this reason enough to discontinue the drugs??

Quote:
Johnson & Johnson (JNJ.N) is required to add new warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations, the U.S. Food and Drug Administration said on Tuesday.

Final results from two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana, known also as canagliflozin, as those given a placebo, the FDA said in an announcement posted on its website.

The warnings include a boxed warning, reserved for the most serious possible adverse events, the FDA said.

Invokana belongs to a relatively new class of type 2 diabetes drugs called SGLT-2 inhibitors, which help remove excess blood sugar through urine. Others in the class include Eli Lilly and Co's (LLY.N) Jardiance and AstraZeneca Plc's (AZN.L) Farxiga.

The FDA noted that results of one clinical trial showed that over the course of a year the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000, compared with 2.8 out of 1,000 for patients given a placebo.

A second trial showed the risk of amputation was equivalent to 7.5 out of every 1,000 patients treated with Invokana compared with 4.2 out of every 1,000 patients given a placebo.

The agency said amputations of the toe and middle of the foot were the most common but that amputations involving the leg, below and above the knee, also occurred.

Untreated type 2 diabetes can cause blindness, nerve and kidney damage and heart disease. http://www.reuters.com/article/us-h...n-idUSKCN18C2RC(My emphasis)


I wonder if we'll hear this warning in their ubiquitous TV ads.
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  #2   ^
Old Tue, May-16-17, 21:51
Meme#1's Avatar
Meme#1 Meme#1 is offline
Posts: 7,789
 
Plan: Atkins DANDR
Stats: 210/183/160 Female 5'4"
BF:
Progress: 54%
Location: Texas
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This is really frightening. The thought that amputations are caused by this drug verses doing nothing and no amputations!
So much better to go Low-carb....
As I was reading this an ad was on TV for Trulisity, another diabetic drug. I wonder what the mortal side effects are caused by that one!
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  #3   ^
Old Tue, May-16-17, 22:50
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robynsnest robynsnest is offline
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Plan: Atkins
Stats: 328/292/199 Female 5'11"
BF:Losing it....
Progress: 28%
Location: Canada ay?
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OMG! Are you kidding me right now, the diabetic clinic was strongly suggesting these medications...trust your gut, scary stuff man.
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  #4   ^
Old Tue, May-16-17, 23:02
Meme#1's Avatar
Meme#1 Meme#1 is offline
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Plan: Atkins DANDR
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BF:
Progress: 54%
Location: Texas
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My DH went from a blood sugar of 325 to about 160 with LC and he now takes Metformin which keeps it normal. If you need to take something to get it down, Metformin has been around for years and he has had no side effects.
LC is the only way to go.....
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  #5   ^
Old Tue, May-16-17, 23:38
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GRB5111 GRB5111 is offline
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Plan: Ketogenic (LCHFKD)
Stats: 227/186/185 Male 6' 0"
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Progress: 98%
Location: Herndon, VA
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Incredible, the beat just keeps going on . . .
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  #6   ^
Old Wed, May-17-17, 23:02
Merpig's Avatar
Merpig Merpig is offline
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Plan: IF/Fung IDM/Potato Hack?
Stats: 375/272.6/175 Female 66 inches
BF:
Progress: 51%
Location: NE Florida
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EEEK. I'm a T2, and my doctor's office is affiliated with a research lab that does drug testing. Currently they are trying to recruit T2's currently on metformin only for a new diabetes drug study and asked me if I would be interested. I teetered a bit as you get paid $50/month and as a retiree on a limited income the idea of $$$ sounded good. But the idea of testing drugs scares me too as you see so many results like this!

The trial is called SUSTAIN 8 and it's stated purpose is:
Quote:
The purpose of this clinical trial is to compare the safety and efficacy of two trials products (semaglutide and canagliflozin) in patients who have only received metformin as a treatment for their type 2 diabetes.
So what are these products? The pamphlet also says:
Quote:
For SUSTAIN 8 two different diabetes treatments will be compared, semaglutide and canagliflozin. Semaglutide is a drug under development by Novo Nordisk and works by mimicking the effect of the naturally occurring gut hormone GLP-1, which increases the level of insulin in the blood, thereby helping control blood sugar levels. Canagliflozin works by blocking a protein in the kidneys called SGLT-2 that transports sugar from the urine and back to the bloodstream. Canagliflozin is an approved treatment for type 2 diabetes developed by Janssen Pharmaceuticals under the trade name Invokana
Hmm, well I'm a Dr. Fung fangirl, and he makes a good case that increasing insulin is the last thing T2s need to do, and now this new news about drug number two! I'm sorry for the folks who have agreed to be part of this study.
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  #7   ^
Old Thu, May-18-17, 04:15
cotonpal's Avatar
cotonpal cotonpal is online now
Posts: 3,249
 
Plan: very low carb real food
Stats: 245/128/135 Female 62
BF:
Progress: 106%
Location: Vermont
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It's absurd. All this money spent on the development of drugs to treat a disease that can be treated if not eliminated successfully by diet change alone, with no harmful side effects, only a host of positive health effects. One might even be tempted to call the development and sale of these drugs criminal, perhaps fraud, malpractice, out right quackery.

Jean
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  #8   ^
Old Thu, May-18-17, 05:45
JEY100's Avatar
JEY100 JEY100 is online now
To Good Health!
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Plan: IF Fung/LC Westman/Primal
Stats: 222/171/169 Female 5' 9"
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Progress: 96%
Location: NC
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Jean

The insult of the ADA recommended diet reminds me of Kelley Pounds opinion piece yesterday. Diabetes is Not a Choice...when following the Advice the USDA and ADA have dished out the past 40 years. https://lowcarbrn.wordpress.com
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  #9   ^
Old Fri, May-19-17, 19:51
JLx's Avatar
JLx JLx is offline
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Posts: 1,812
 
Plan: IF
Stats: 210/191/165 Female 66
BF:High wt, 276, 255
Progress: 42%
Location: Michigan U.P., USA
Default

I am dismayed that there has been no outcry about this. Not even any other news reports. I have diabetes as one of my personalized topics on Google News is how I saw it. Remember the stink about previous drugs, such as Vioxx? I guess amputations for diabetes are seen as business as usual.


My mother watches cable news every day and Invokana is advertised there every morning. No change in their list of side effects and warning yet. I suppose the lawyers are on the job trying to block it or water it down. I hope their stock price took a momentary hit at least!

Incidentally, I would say this result is just another indictment of the idea of lowering blood sugar not being what it's all about. I'm a little curious about why the increased risk of amputations, what the mechanism is, but I probably wouldn't understand the science even if I knew it.
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  #10   ^
Old Fri, May-19-17, 22:40
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Meme#1 Meme#1 is offline
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Plan: Atkins DANDR
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Location: Texas
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Just a wild guess, I would imagine it effects circulation?
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  #11   ^
Old Sat, May-20-17, 04:22
JEY100's Avatar
JEY100 JEY100 is online now
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Plan: IF Fung/LC Westman/Primal
Stats: 222/171/169 Female 5' 9"
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Progress: 96%
Location: NC
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Quote:
Incidentally, I would say this result is just another indictment of the idea of lowering blood sugar not being what it's all about.

This is what Dr Fung claims in his talk...the lower blood sugar does not stop the progress of the disease. It may be with Innokana the patient felt good when FBG was low in the am, then goes on to eat the recommended ADA the rest of the day, while the disease progresses at the same pace. The placebo group didn't get lower BG and watched their diet more carefully rest of day? Though the difference is large enough to point to the drug mechanism of removing sugar through urine, as Meme says circulation.

There was an alert issued on this class of drugs last year, Europe added the warning early this year, and the FDA finally joined them. Dr Westman warned about them last year for the Keto acidosis and heart attack risk in a talk.
There are already lawsuits and PI attorneys circling around the drug.
http://www.drugdangers.com/invokana/lawsuit

The announcement on MedPage:

Quote:
WASHINGTON -- Labels for type 2 diabetes drugs containing canagliflozin (Invokana, Ivokamet, Invokamet XR) will now carry a boxed warning about increased risks of leg and foot amputation, the FDA said Tuesday.

The warning comes after the agency reviewed data from two randomized, placebo controlled trials (CANVAS and CANVAS-R) that showed rates of lower-extremity amputations were doubled in the active drug groups, irrespective of dose. Among nearly 6,000 patients receiving canagliflozin in the two trials, rates of amputations were 5.9 and 7.5 per 1,000 patient-years, compared with 2.8 and 4.2 per 1,000 patient-years in the placebo groups.

The differences were statistically significant. CANVAS was the FDA-required study investigating cardiovascular outcomes; CANVAS-R assessed renal endpoints. Lower-limb infections, gangrene, diabetic foot ulcers, and ischemia were the most common precipitating factors for amputations in the studies, the FDA said. Patients with previous amputations were more likely than others to need additional ones during the trial. Notably, patients in the two trials were included only if they had cardiovascular disease or risk factors for it other than type 2 diabetes.

However, the new warning applies to all patients regardless of cardiovascular risk. The FDA urged prescribers to consider individual patients' risks for amputation before initiating canagliflozin. Patients currently on the drug should be monitored closely for conditions such as infections and foot ulcers that may lead to amputation; the drug should be discontinued if these appear. Almost exactly 1 year ago, the FDA issued an alert about interim results from the two trials that suggested the increased amputation risk, and promised an update when fuller data were available.

Canagliflozin is one of the new class of SGLT-2 inhibitors that reduce blood glucose levels by inducing sugar to be excreted in urine. The FDA has not said other SGLT-2 inhibitors may have the same risk of amputations, but in February, the European Medicines Agency indicated that it may be a class effect. Other SGLT-2 inhibitors include dapagliflozin (Farxiga) and empagliflozin (Jardiance).

Last edited by JEY100 : Sat, May-20-17 at 06:36.
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  #12   ^
Old Sat, May-20-17, 11:17
Meme#1's Avatar
Meme#1 Meme#1 is offline
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Plan: Atkins DANDR
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Location: Texas
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From the link of drug dangers:
Quote:
they believe itís linked to the way in which the drug affects the vascular system. When not enough oxygen and nutrients reach the extremities, it can cause cell death.


This is horrible and by the time a patient is effected, can you imagine how ill they are if not deceased.

Thanks Janet!
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  #13   ^
Old Sat, May-20-17, 12:12
JEY100's Avatar
JEY100 JEY100 is online now
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Plan: IF Fung/LC Westman/Primal
Stats: 222/171/169 Female 5' 9"
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Progress: 96%
Location: NC
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A black box warning? Why hasn't this been pulled from the market????
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  #14   ^
Old Sat, May-20-17, 12:41
Meme#1's Avatar
Meme#1 Meme#1 is offline
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Plan: Atkins DANDR
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It also causes Ketoacidosis and I just wonder about how many times I have smelled people in that condition and thought they were untreated diabetics but now I wonder if they were on these drugs thinking it was helping them.

Exactly Janet, it should be pulled from the market!
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  #15   ^
Old Sat, May-20-17, 21:25
Merpig's Avatar
Merpig Merpig is offline
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Plan: IF/Fung IDM/Potato Hack?
Stats: 375/272.6/175 Female 66 inches
BF:
Progress: 51%
Location: NE Florida
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Quote:
Originally Posted by JEY100
A black box warning? Why hasn't this been pulled from the market????
Apparently Tylenol has a black-box warning too, as does Cipro - which I was prescribed for a UTI a couple months ago. I called back the office in concern when I picked up the prescription and saw all the warnings, and the nurse almost laughed at me, implying I was a worrywort, and saying I'd be far worse off NOT taking it than I would be taking it. But I later read the FDA site which even said it's often used for UTI's - but should only be given as a *LAST RESORT* and never as a first prescription, and special care should be taken in folks over 60 as it can cause severe mental problems as well as physical - yet things like this are still routinely prescribed.
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