Invokana and Farxiga Acute Kidney Injury Warning Issued by FDA

Austin Kirk

By Austin Kirk
Posted June 15, 2016

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The FDA issued a new warning this week, which provides important support for Invokana lawsuits, Invokamet lawsuits, Farxiga lawsuits and Xigduo XR lawsuits being pursued by our lawyers for individuals throughout the U.S. who suffered kidney failure or kidney damage following use of diabetes drugs that are part of this new class of medications.

In a drug safety communication released June 14, the FDA announced that the manufacturers of these new diabetes medications will be required to provide stronger warning for users and the medical community about the risk of acute kidney injury.

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Invokana (canagliflozin) was introduced only three years ago, as the first member of a new generation of diabetes treatments known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.

Farxiga (dapagliflozin) was the second member of this new class, and the manufacturers of each drug introduced a separate medication that combines these new drugs with metformin, marketed as Invokamet and Xigduo XR.

Although the medications were aggressively marketed and promoted as soon as they hit the market, encouraging many diabetics to switch to these new treatments, it has become clear that the medications were not adequately tested and individuals face serious health risks from side effects of Invokana, Farxiga, Invokamet and Xigduo XR.

According to the FDA, there have been at least 101 reports of acute kidney injury from Invokana and Farxiga identified by federal health officials, which likely only represent a small portion of the total number of kidney problems linked to the medications. In nearly all of the cases, individuals were hospitalized, and several of the cases may have resulted in kidney failure requiring dialysis treatment or death.

Acute kidney injury, which is sometimes referred to as acute renal failure, involves an abrupt loss of kidney function. This can cause a number of serious health problems, potentially leading to chronic kidney disease, kidney failure or wrongful death.

The Invokana and Farxiga warning provided by the FDA indicates:

Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful.

Invokana and Farxiga Kidney Injury Lawyers

Unfortunately, these warnings are long overdue and many individuals may have avoided severe and potentially life-threatening injuries if the drug makers had adequately disclosed the kidney risks. The pharmaceutical companies knew or should have known that users face an increased risk of acute kidney injury, yet information was withheld from those prescribed Invokana, Invokamet, Farxiga or Xigduo XR.

Unlike other diabetes drugs, this new class of medications work in a unique way by altering kidney function to allow them to pass more glucose out of the body with the urine.

Shortly after the drugs hit the market, a surprisingly high number of adverse event reports were identified, suggesting a clear link between Invokana and kidney problems.

In May 2015, the Institute for Safe Medication Practices (ISMP) highlighted these problems, raising questions about why the risk was not identified before the drugs were introduced and whether the minimal benefits provided by the drug are outweighed by the side effects.

In addition to updating the warnings about the risk of acute kidney injury, since the drugs hit the market, the FDA has issued updated warnings or safety statements about other health risks, including:

  • Diabetic Ketoacidosis
  • Bone Fractures
  • Increased Amputation Risk
  • Dangerous Kidney and Urinary Tract Infections

As a result of the drug makers’ apparent decision to place their desire for profits before consumer safety, the Invokana kidney injury lawyers at Saiontz & Kirk, P.A. are pursuing financial compensation for individuals throughout the United States.

All cases are being pursued under a contingency fee agreement, which means there are no attorney fees or expenses unless a recovery is obtained.

To review whether you or a loved one may have a claim, request a free consultation and case evaluation.

1 Comment • Add Your Comments

  • Sallie T says:

    I have kidney disease and have taken the named prescriptions for my kidneys.

    Posted on December 2, 2018 at 5:57 am

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