Invokana Warnings Update Required by FDA

Austin Kirk

By Austin Kirk
Posted December 8, 2015


The FDA has finally announced that stronger warnings will be required for a popular new generation of diabetes drugs, known as SGLT2 inhibitors, providing further support for Invokana lawsuits, Farxiga lawsuits and other failure to warn claims being investigated by the lawyers at Saiontz & Kirk, P.A.

In a statement issued late last week, the FDA indicated that the Invokana warning label will be updated to include crucial information for users, stating that users should immediately stop using the medication and seek medical attention if they experience side effects of ketoacidosis, which may include:

  • Abdominal Pain
  • Fatigue
  • Nausea
  • Respiratory Problems
  • Vomiting

In addition, the FDA urges patients to seek immediate medical treatment if they suspect they may have a urinary tract infection on Invokana or other members of this new class of diabetes drugs, as it could be a sign of a kidney infection that could result in Invokana kidney failure and the need for dialysis.

The FDA warning update for Invokana, Farxiga and other SGLT2 inhibitors comes as the makers of these recently introduced diabetes drugs face a growing number of complaints filed in courts throughout the U.S., which allege that inadequate warnings have been provided for provide consumers and the medical community.

As we wrote last month, stronger Invokana warnings may have helped individuals avoid serious health problems by allowing them to choose a different diabetes treatment or more closely monitor or signs of side effects.

Invokana Kidney Infection and Ketoacidosis Symptoms

According to the drug safety communication issued by the FDA, the manufacturers of all SGLT2 inhibitors, including Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi, must add new information to the Warnings and Precautions section of the drug label regarding the risk of infections and ketoacidosis, which involves an accumulation of acid within the blood.

In addition, the drug makers are being required to conduct additional studies to analyze reports of ketoacidosis problems with Invokana and other related diabetes drugs, including follow up to collect information over a period of at least five years. According to allegations raised in lawsuits filed, these studies should have been conducted before the drugs were ever introduced and promoted as a superior treatment for type 2 diabetes.

The FDA originally warned about the potential link between Invokana and ketoacidosis in May 2015. This new update indicates that at a review of the agency’s adverse events database found at least 73 cases where users of the diabetes drugs were diagnosed with elevated blood acid levels, all resulting in the need for hospitalization.

Injury Lawyers

Find Out If You or a Loved One Have an Invokana Warning Claim


In addition, at least 19 cases of blood infections (urosepsis) and kidney infections (pyelonephritis) were identified, all of which initially presented as urinary tract infections. In some cases, the Invokana infections resulted in kidney failure and the need for treatment in a hospital intensive care unit (ICU) or dialysis treatment.

The findings raise serious concerns about the safety of Invokana, Farxiga and these other new-generation treatments, as the mediations have only been on the market for about two years.

In addition, FDA adverse event reports typically only capture a small fraction of actual problems associated with prescription drugs, as most problems are never linked to the medication or reported to the FDA.

The Invokana lawyers at Saiontz & Kirk, P.A. provide free consultations for individuals and families throughout the United States, to help determine if financial compensation may be available as a result of:

  • Diabetic Ketoacidosis, Ketosis or Acidosis
  • Urinary Tract Infections, Blood Infections or Kidney Infections
  • Kidney Failure

All cases are being reviewed under a contingency fee agreement, which means that there are no out of pocket expenses to hire our lawyers and we receive no attorney fees unless a settlement or recovery is obtained. To find out if you or a loved one may have a lawsuit, request a free consultation and claim evaluation.

No Comments • Add Your Comments

Add Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide contact information below and additional private comments if you want an attorney to contact you to review a potential case.

    The information below will not be published to this page.

  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.