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Invokana and Other SGLT2 Inhibitors Might Double the Risk of Diabetic Ketoacidosis (DKA)

By Karissa Klotsche on November 13, 2017

FDA Invokana Diabetic Ketoacidosis Warnings

Invokana is Johnson & Johnson’s brand name for Canagliflozin which was approved by the FDA in March 2013.  Invokana and other SGLT2 inhibitors (Sodium-glucose contransporter-2 inhibitor) lower blood sugar by causing the kidneys to excrete glucose through the patient’s urine, reducing the amount of glucose in the patient’s blood.  However, crucial blood components have also been found to excrete from the patient’s kidneys as well, allegedly leading to severe side effects and complications.

Besides leg and foot amputations, ketoacidosis is another serious side effect that can happen when taking Invokana (Canagliflozin).

Ketoacidosis is a serious, potentially life-threatening medical condition in which the patient’s body cannot properly metabolize blood acids (ketones). Ketone buildups may cause the blood’s pH to drop to unsafe levels, possibly resulting in diabetic coma or death if the condition is left untreated.

Invokana studies conducted at the University of San Diego this summer appear to show a link between taking the drug to treat type 1 diabetes and developing ketoacidosis.

In May 2015, the Food and Drug Administration (FDA) issued a Drug Safety Communication warning Invokana users the type 2 diabetes drug could cause ketoacidosis.

The 8-week study consisted of following 351 Type 1 Diabetes patients who were between the ages of 25 and 65. Participants were given either placebo, 100 mg or 300 mg doses of Invokana. No one in the placebo group developed diabetic ketoacidosis while five of the 100 mg participants and seven 300 mg participants developed the condition.

In June 2016, the FDA required additional label warnings about the link between Invokana and kidney risks, highlighting that the medication may increase the risk of acute kidney injury.

In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, emphasizing that the medication significantly increases the risk of this potentially deadly condition.

Patients were advised by the FDA to stop taking Invokana and to seek medical attention immediately if they have any symptoms of ketoacidosis.

Besides Diabetic Ketoacidosis, other severe Invokana side effects have been discovered including Invokana amputation risks, kidney failure, heart attacks and other catastrophic injuries.

 

It is important to know that if Diabetic ketoacidosis (DKA) is not treated, it can lead to severe illness or death. In more detail, possible complications of DKA include these medical conditions:

  • Cerebral Edema (fluid buildup in the brain)
  • Bowel Necrosis (death of bowel tissue due to low blood pressure)

We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients who have developed Diabetic ketoacidosis (DKA).

 

Visit our website for more information and see if your claim qualifies at http://InvokanaLegalHelp.com/qualify OR

Call To Start Your Claim…  (877) 963-2806

invokana amputation and ketoacidosis claims

 

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INVOKANA AND INCREASED RISK FOR AMPUTATIONS GETS FDA BLACK BOX WARNING

Invokana (canagliflozin), an SGLT-2 drug for use in type 2 diabetes (and sometimes type 1) is now required to carry the eminent black box warning by the FDA due to a higher risk for foot and leg amputations. Canagliflozin is the drug present in the marketed products: Invokana, Invokamet and Invokamet XR. It is a drug prescribed for use in combination with exercise and diet to lower blood sugar by forcing the kidneys to move sugar out of the body by excreting it through the urine.

This new requirement is a result of 2 clinical trials whose data revealed these elevated risks. The clinical trials uncovered that foot and leg amputations happened twice as often in those taking Canagliflozin compared to those taking a placebo. There were 2 clinical trials which concluded these revealing results; CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus).

Invokana is Johnson & Johnson’s brand name for Canagliflozin which was approved by the FDA in March 2013. Invokana and other SGLT2 inhibitors (Sodium-glucose contransporter-2 inhibitor) lower blood sugar by causing the kidneys to excrete glucose through the patient’s urine, reducing the amount of glucose in the patient’s blood. However, crucial blood components have also been found to excrete from the patient’s kidneys as well, allegedly leading to severe side effects and complications.

Over the length of a year, the risk for amputations for CANVAS trial patients was equivalent to 5.9 out of every 1,000 pateints taking canagliflozin and 2.8 out of every 1,000 patients taking a placebo.

Over the length of a year, the risk for amputations for CANVAS- R trial patients was equivalent to 7.5 out of every 1,000 patients taking canagliflozin and 4.2 out of every 1,000 patients taking a placebo.

The most common amputations were the toe and foot amputations, however, above and below the knee leg amputations also occurred, some even needing more than one amputation involving both limbs.

If you or a loved one has taken Invokana or other SGLT2 inhibitor and believe an injury was caused as a result, it is recommended you speak with an attorney because you may be entitled to compensation under the MDL litigation process or via settlement. Our attorneys hold drug and medical device manufacturers liable when their products endanger the public. Our attorneys are actively pursuing Invokana settlements and filing Invokana lawsuits against manufacturers on behalf of patients injured or killed from use of these potentially harmful drugs.