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Invokana LawsuitSGLT-2 Inhibitors Can Cause Dangerous Side Effects

Invokana Lawsuit

Patients who have previously been prescribed Invokana -- or similar SGLT-2 inhibitor -- and been injured by the drug may be eligible to participate in an Invokana lawsuit.

At this time, TorHoerman Law is still taking in new Invokana lawsuit cases for certain injuries. Contact TorHoerman law today to see if you are eligible to participate in the Invokana lawsuit.

Litigation Updates

Negotiations Continue for Lawsuits

April 2018 - We are in negotiations regarding diabetic ketoacidosis cases, and are hopeful that we will hear more, soon.  We are ramping up cases for other kidney injury and for amputations of the leg, feet, or toes.

FDA Issues Black-Box Warning

May 2017 -- The FDA issues a black-box label for Invokana and other SGLT-2 inhibitors warning consumers of the higher risks of lower limb amputation for patients using SGLT-2 inhibitors. 

The risks of amputation were twice as high for patients using Invokana or similar SGLT-2 inhibitors.

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FDA Releases New Warning of Acute Kidney Injury

June 2016 -- The FDA introduces new warning for Invokana, Invokamet, Farxiga, and Xigduo XR, linking the SGLT-2 inhibitors to reports of acute kidney injury that required hospitalization in some cases.

FDA Issues Consumer Safety Alert

May 2016 -- The FDA issues a consumer safety alert for SLGT-2 inhibitors.

FDA Revises Drug Label

September 2015 -- The FDA revises Invokana and Invokamet labels to include information about the risk of bone fracture.

FDA Issues Drug Safety Communication

May 2015 -- The FDA issues a drug safety communication stating that Invokana, Farxiga, and Jardiance may lead to ketoacidosis, and highlighted 20 cases of acidosis in patients treated with SGLT-2 inhibitors from March 2013 to June 2014.

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What is Invokana?

Invokana, approved by the U.S. Food and Drug Administration (FDA) in 2013, is part of a class of Type 2 diabetes drugs called sodium-glucose cotransporter-2 (SGLT-2) inhibitors. SGLT-2 is a protein in humans that facilitates glucose reabsorption in the kidneys, and SGLT-2 inhibitors block the reabsorption of glucose in the kidneys, increase glucose excretion, and in turn lower blood glucose levels. SGLT-2 inhibitors are commonly used to treat adults with Type 2 diabetes.

Studies and trials have shown Invokana, and similar SGLT-2 drugs to be highly effective in controlling blood glucose levels and lowering hemoglobin levels for patients with Type 2 diabetes.

Because of its effectiveness, the popularity of Invokana has increasingly grown since its market introduction. Invokana is considered the most popular drug in its class.

However, Invokana and similar medications have been linked to a number of dangerous and potentially life-threatening adverse health effects.

 

Invokana – The First SGLT-2 Inhibitor

Invokana was the first drug of its class, approved for market in 2013. Invokana is manufactured by  Johnson & Johnson subsidiary, Janssen Pharmaceuticals. Invokamet was approved in 2014. Invokamet XR was approved in 2016.

 

Adverse Effects Associated with Invokana Explained

Despite its notable ability to control blood sugar levels, Invokana has some potentially serious side effects:

  • Kidney damage – Kidney failure occurs when the kidneys stop functioning without the help of dialysis or a kidney transplant. Kidneys help filter waste products from the blood, so when they stop functioning properly, electrolytes, fluids, and waste products build up in the body and cause abnormal heart rhythms, confusion, shortness of breath, weakness, and death.
  • Amputations – Clinical trials have found that Invokana users are twice as likely to suffer from lower limb amputation as compared to patients using a placebo. The risks are even higher for patients who have already suffered from a previous amputation. Invokana users should look for signs – infections in lower limbs, tenderness, sores – talk to a doctor right away if you experience any of these symptoms.
  • Ketoacidosis – When the body is unable to produce enough insulin, ketoacidosis develops. Without enough insulin, the body breaks down fat as an alternative source of energy, which in turn produces a buildup of toxic acids in the bloodstream known as ketones. When untreated, excess ketones in the blood result in ketoacidosis, which can lead to diabetic coma, hospitalization, and death.

Starting in 2015, the FDA began to release multiple public safety announcements, warning the public of the links between Invokana/SGLT-2’s and these dangerous adverse effects.

 

Other SGLT-2 Drug Warnings

Following the release of Invokana, the FDA approved drugs in the same SGLT-2 class. All though they carry a different brand name, these follow-up drugs carry the same risks and warnings as Invokana and Invokamet. These follow-up SGLT-2 inhibitors also include:

  • Jardiance
  • Farxiga
  • Xigduo XR
  • Glyxambi

 

Farxiga

Farxiga was first approved for market in 2014, after being rejected for approval by the FDA in multiple prior pre-market trial phases.

Farxiga is similar to most other SGLT2 inhibitors, with the distinction of being five times more likely to cause bladder cancer. Farxiga may also increase the progression of bladder cancers in patients who are prone to bladder cancer, according to studies conducted by the Cancer Prevention & Treatment Fund

 

Current Invokana Lawsuit

 A conglomeration of patients has already filed a multi-district Invokana lawsuit against the manufacturer, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

The Invokana lawsuit claims Invokana/Janssen:

  • Is a defective and unreasonably dangerous product
  • Puts patients at risk of amputation, kidney damage, and ketoacidosis.
  • Manufacturer, Janssen Pharmaceutical, failed to warn consumers of these known risks.
  • Janssen failed to test Invokana for all possible side effects.
  • The company also held in-house data, which indicated the dangers of the drug, from the FDA and consumers.

The lawsuits have consolidated into a multidistrict litigation — MDL No. 2750 — in the courts of New Jersey. As of January 2018, there are more than 990 cases involved in the MDL.

The first bellwether trial is scheduled to begin in September 2018.

There are also Invokana lawsuits pending in federal court in Missouri and California. There are individual cases in state court in New Jersey, California, and Pennsylvania.

 

Participating in the Invokana Lawsuit

If you or a loved one was taking Invokana (or a similar SGLT-2) to treat Type 2 diabetes and suffered injuries from the drug, you may be entitled to compensation for your damages with a Type 2 diabetes lawsuit.

TorHoerman Law is currently pursuing only certain injuries related to Invokana.  Contact the office of TorHoerman Law, for a free no-obligation Invokana lawsuit case assessment today to learn whether you are eligible to participate in the Invokana lawsuit.

 

Deadlines to Participate in the Invokana Lawsuit

Individuals who took Invokana or other SGLT2 drugs and suffered pyelonephritis, ketoacidosis, or urosepsis prior to December 4, 2015, may be able to participate in the Invokana lawsuit.

Individuals who took Invokana or other SGLT2 drugs and suffered lower limb and toe amputations or gangrene of these limbs before August 2017, may be able to participate in the Invokana lawsuit.

Individuals who took Invokana or other SGLT2 drugs and suffered renal failure or acute kidney injury before December 4, 2015, may be able to participate in the Invokana lawsuit.

 

 

 

+ - References

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204042s026lbl.pdf

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