Invocana Risk for Amputation by FDA Boxed warning. May 21, 2017

The US Food and Drug Administration (FDA) has issued a new boxed warning to the label of canagliflozin (Invokana, Invokamet, Janssen) to describe the risk for leg and foot amputations. http://ift.tt/2qHnoHv

Ok, now what? If there is some risk then there something must be done to avoid the issue to happen, what is this?

A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus ― indicate an approximate doubling of the risk for both leg and foot amputations in canagliflozin-treated patients compared to those randomly assigned to receive placebo.

This is too risky to take medicine which double diabetics' risk for amputation of both legs. Also there is good question, why it is so high rick that both legs can be amputated at the same time or in closer time? For me it looks like it is one problem, big one, why diabetic lost both legs. And what about other organs? What about mortality rate with Invokana, Invocanamet, and Janssen?  Really there is the question, if medicine is too risky to take then why this medicine must be taken by victim? Of cause it is easy to post box and say that do not take this medicine if.... and contact doctor  right away, but what doctor would suggest?

Before prescribing canagliflozin, the FDA advises healthcare professionals to consider factors that may predispose patients to amputations, including a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.

FDA advice? Really what is this about?  So, diabetic who already has prior amputation, why this was happened? Was the problem solved? Not at all. Diabetic still has high blood sugar and Invokana is blood sugar lowering medicine, at least as it is presented. Then why amputation got in first place? Was Invokana effective to reduce blood sugar level? Was it is effective medicine to treat diabetic type 2? Most important when diabetes type 2 progressed to the point when gangrene is on the table say me, is this really true that there is no foot ulcers, CVD, or neuropathy? They are all already present,. So, why Incokana Rx in first place?
       If Invokana lead to amputation and all complications such as CVD, neuropathy, and foot ulcers, then it is best way to do Rx Invokana. It does not work safely for diabetics type 2 and lead to develop very danger, life threatening complications. Not at all. Invokana got warning box in its table. Then there are other studies would be done, paid by manufactures, and a new studies would prove, there is no rick for amputations. Warning box would be removed. Regardless of warning box in the medicine lable, diabetics type 2 would get surgeon knife and legs would be cut off below or above the knee.

Patients taking canagliflozin should be monitored for signs and symptoms of those conditions. The drug should be discontinued if these complications occur.      

Well, it is very easy to say to discontinue drug, the problem how to do so? Before drug would be discontinued it must be replaced by another one. It is not possible just take off medicine if one has chronicle medical condition. So, before Invokana would be discontinued, it would be replaced by Invokanamet, then Janssen would replace Invokanamet, and soon all of them would be replaced in another way of replacement therapy. If it is not this medicine then which one to replace Invokana? FDA better to advice, or recommend, but it is even better to have protocol what doctor must do if one medicine does not work, which one must replace it? All what doctor do just practice Art Of Medicine, each one as one may.
       There is another problem with replacement of Invocana. Invokana is strong, very strong diuretic. Leg amputation is result of water retention, Edema. How FDA suggest to treat Edema in Diabetics type 2? If Invokana would be cut off from medical regime, Edema would be increased. No one other diuretic would be more effective to cut Edema as it is Invokana. Diabetic type 2 and doctor sit inside of trap. If Invokana cut off then Edema kill Diabetic type 2. If Invokana still in treatment regime then it is Amputation. The choice is hard, but obvious. Doctor would avoid to discontinue Invokana.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

What for? Invokana must not be on market in first place. It is not medicine to treat diabetes type 2 in first place. After medicine was started it is very very difficult to avoid its complications. Invokana Deadly March is took off and not is is wide and strong.

The European Medicines Agency has been investigating this phenomenon since April 2016, and in February 2017 issued a requirement that the labels of all drugs of the sodium glucose cotransporter 2 (SGLT2) inhibitor class carry the amputation warning.

I am wander, does this medicine still carry on other warnings? As I do remember there were other boxes in label, such as CVD warning, stroke warning? Are they stay present in label or they were taken off?

 The whole idea of these agents are : insulin/beta cell independent effect with added benefits like weight and BP. These are in fact the factors to prevent complications like amputations !!

Looks like it does not the issue. Complications are not developed but the resulted by medicine. Another interesting question, is medicine worked out diabetes type 2 problem? Did it increased insulin in blood stream? Good question, bad answer. It is not. If so then medication such as Invokana what for? And finally, what does it mean, 'insulin/beta cell independent effect'? It mean that diabetes type 2 has no meaning, no description, no clear understanding what is it and how to address to the problem. So, there is no answer possible in not fat future. So, our studies would develop a new types of Invokana, and lead us to  double increase doubled rick for amputations and death penalty for wrong life style. At least it is easy to say, we did it for ourselves. We are only to whom to blame.

With so much of adverse reactions associated with these molecules i always wonder why FDA approved these molecules.

Good question. No good answer. Before try to get answer to this question try to ask, what is diabetes type 2? based on what diagnose diabetes type 2 determined? There is no answer to this question. Diabetes is disease of pancreas, but diagnosed not according to health of pancreas but level of sugar in blood. This level of sugar in blood based on so many evidence that it is not possible to relay on the test. So, how diagnose of diabetes type 2 made? If there is no diagnose, no mark how to check up if medicine wars or not then there is no any prove that Invokana was effective in first place. If so then what was left? What for diabetic type 2 takes Invokana? 

via Ravenvoron