Update: FDA Requires Boxed Warning on Amputation Risk with Invokana

May 16, 2017 – Based on the final results of 2 long-term clinical trials, FDA has concluded that type 2 diabetes patients who take Invokana or Invokamet are twice as likely to have their foot or toe amputated. As a result of these findings, the agency is requiring that both medications carry a boxed warning regarding the amputation risk.

What is Invokana?

Invokana (generic: canagliflozin) is a prescription medication used to improve glycemic control in patients with type 2 diabetes. The drug works by promoting the dumping of glucose (sugar) from the kidneys to the urine. Invokana was developed by Mitsubishi Tanabe Pharma, and is marketed under license by Janssen Pharmaceuticals, a division of Johnson & Johnson.

FDA Investigating Injuries Linked to New Diabetes Medications

On May 15, 2015, the U.S. Food & Drug Administration (FDA) issued a warning which stated that Invokana and other similar diabetes medications had been linked to a serious health complication called diabetic ketoacidosis (also known as DKA, diabetic acidosis, metabolic acidosis and ketoacidosis). If left untreated, this condition may result in diabetic coma or even death.

The agency’s warning came in response to at least 20 reports of ketoacidosis in patients who took diabetes drugs from the sodium-glucose cotransporter-2 (SGLT2) inhibitor class. All 20 patients had to go to an emergency room or were hospitalized, according to the FDA.
Ketoacidosis typically affects people with type 1 diabetes; however, all of the cases reported to the FDA involved type 2 diabetics, and the condition manifested itself slightly differently than in patients with type 1 diabetes. As a result of these problems, on Dec. 4, 2015, the agency required labels of SGLT2 inhibitors to be updated with information about the ketoacidosis risk.

Diabetes Drugs Linked to Ketoacidosis & Kidney Failure: Ring of Fire Video

Signs of Ketoacidosis

The FDA urged patients to seek immediate medical attention if they experience symptoms of ketoacidosis, which may include:

  • Difficulty breathing
  • Nausea
  • Vomiting
  • Abdominal pain
  • Confusion
  • Unusual fatigue or sleepiness


Treatment for patients with diabetic ketoacidosis involves administering fluids intravenously to avoid dehydration, and to replace any salts that were lost through excessive urination. Insulin may also be required to suppress ketones that the body produces. Close observation of the patient to identify and prevent complications is critical, which is why most DKA patients will be treated in a hospital setting until their ketone levels have stabilized and they have returned to eating normally.

FDA Recommendation

Patients taking Invokana or other diabetes medication should monitor themselves for signs of ketoacidosis and seek immediate medical attention if they develop any of the symptoms listed above. FDA advises patients not to stop taking any prescription medication without talking to their doctor first. If tests confirm that a patient has ketoacidosis, doctors should discontinue treatment with the drug and take appropriate action to correct the condition.

How to Lower Your Risk of Ketoacidosis

In a recent article published in Diabetes Care by the American Heart Association (AHA), authors Dr. Julio Rosenstock and Elle Ferrannini said that the responsibility of lowering the risk of ketoacidosis should begin with medical professionals, who should work to evaluate patients for pre-existing factors which put them at increased risk for the condition. They recommend that patients with risk factors be closely monitored for metabolic changes on a regular basis. Additionally, the authors state that risk factors which can lead to DKA may include:

  • Patients who have recently been ill;
  • Patients who have lowered food and liquid intake;
  • Patients with a history of alcohol use;
  • Patients with latent autoimmune diabetes,
  • And those with long-standing diabetes with B-cell insufficiency.

ISMP Report Outlines Health Risks of SGLT2 Inhibitors

On January 13, 2016, the Institute for Safe Medication Practices (ISMP) issued a QuarterWatch Report (PDF) detailing adverse events associated with SGLT2 inhibitor diabetes drugs. The report found that:

  • Both prescription volume and adverse event reports for SGLT2 inhibitors are increasing rapidly;
  • By the 2nd half of 2015, there were 1.1 million prescriptions filled for Invokana, 411,000 for Farxiga and 136,000 for Jardiance;
  • Over the last year, at least 168 FDA adverse event reports involving metabolic acidosis were linked to Invokana, 80 with Farxiga and 12 with Jardiance, and
  • The most commonly reported side effect associated with the drugs was genital fungal infections, which in clinical trials affected 11.4% of female Invokana users, and 3.7% of men.

“Despite the lack of long-term data on safety and benefits, these new drugs have moved rapidly into widespread clinical use, according to data from IMS Health,” ISMP said. “We observed increasing numbers of reports of metabolic acidosis – a potentially life-threatening disorder that has been the focus of two FDA Drug Safety Communications.”

Invokana May Increase Bone Fracture Risk: FDA Warning

In a Drug Safety Communication issued September 10, 2015, FDA announced that it had updated the labeling of canagliflozin-based diabetes medications (Invokana, Invokamet) to note that the drugs may increase the risk of bone fracture and decrease bone mineral density. According to the warning, fractures may occur in as little as 12 weeks after initiating treatment.

Invokana Side Effects

  • Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Acidosis, Ketoacidosis)
  • Heart Attack
  • Amputations of the Leg, Foot or Toes
  • Kidney Failure (Renal Failure)
  • Kidney Cancer
  • Kidney Stones
  • Bone Fractures
  • Bone Abnormalities
  • Stroke
  • Testicular Cancer
  • Urinary Tract Infections (UTIs)
  • Severe Dehydration / Fluid Imbalance
  • Abnormal Weight Loss
  • Hypersensitivity (Allergic Response)
  • Blood Infections (Urosepsis)
  • Fungal Infections
  • Yeast Infections (both men and women)

Invokana Kidney Failure

Kidney failure occurs when the kidneys lose the ability to balance fluids and remove waste from the body. Because SGLT2 inhibitors like Invokana work by removing glucose from the body, they are contraindicated for patients with pre-existing kidney impairment, and may be associated with kidney complications in otherwise healthy diabetes patients. Signs and symptoms of kidney failure include:

  • Nausea
  • Fatigue
  • Confusion
  • Decrease urine output
  • Fluid retention
  • Drowsiness
  • Chest pain or pressure
  • Seizures
  • Shortness of breath

Which Diabetes Drugs are SGLT2 Inhibitors?

In addition to Invokana, other SGLT2 inhibitor diabetes medications linked to adverse health risks include:

Invokana Kidney Failure Lawsuit Filed in New Jersey

May 1, 2017 – A New Jersey woman who allegedly developed an acute kidney injury that led to end-stage renal disease (kidney failure) less than 2 months after taking Invokana for the first time has filed a products liability lawsuit against Janssen and J&J. Plaintiff Jessica Calongne claims that her injuries were preventable and the result of manufacturers’ failure to adequately test Invokana and warn the public and medical community about its potential health risks.

Indiana Woman Alleges Ketosis from Invokana

April 6, 2017 – A woman from Indiana who claims that side effects of Invokana caused her to develop severe dehydration and profound ketosis has filed a products liability lawsuit in the U.S. District Court for the District of New Jersey. Plaintiff Teresa Ross was prescribed Invokana in 2013 for the treatment of type 2 diabetes, and developed starvation ketosis and dehydration in May 2015 as a result of her use of the drug, according to the lawsuit.

Court Establishes ‘Benefit and Expenses Fund’ for Invokana MDL

March 30, 2017 – A Common Benefit Fee and Expense Fund has been established in the Invokana MDL “to provide for the fair and equitable sharing among plaintiffs and their counsel” for expenses incurred during the litigation process. The funds apply to all Invokana and Invokamet lawsuits pending in MDL No. 2750, according to a Pretrial Order issued last week.

Plaintiffs Fight to Stop Transfer of Invokana Lawsuits to New Jersey

January 12, 2017 – More than 100 plaintiffs with lawsuits alleging kidney damage from Invokana are challenging Janssen’s attempt to transfer the cases to the multidistrict litigation (MDL) in New Jersey. Janssen recently filed a motion seeking to stay and then transfer or dismiss 106 Invokana lawsuits that were originally filed in Pennsylvania state court. Plaintiffs responded to the motion Monday, arguing that the transfer would go against “virtually all of” the factors courts should consider when trying the cases.

Invokana Lawsuits Consolidated in New Jersey

December 19, 2016 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federal lawsuits alleging kidney failure and diabetic ketoacidosis from Invokana and Invokamet will be transferred to the District of New Jersey for pretrial handling before Judge Brian R. Martinotti. J&J and Janssen currently face about 55 such complaints in courts across the U.S. However, it is expected that this number will grow into the hundreds or even thousands by the time the litigation process is complete.

Janssen Wants Invokana Lawsuits Transferred to New Jersey

December 1, 2016 – Janssen Pharmaceuticals is seeking to move over 100 Invokana lawsuits from the Philadelphia Court of Common Pleas to federal court in New Jersey. Plaintiffs’ counsel proposed that the cases be consolidated and tried together as part of a mass tort proceeding in state court; however, Janssen has pointed to the Class Action Fairness Act (CAFA) as the basis for removal to federal court.

Invokana Litigation Could Become MDL

September 30, 2016 – Two plaintiffs have requested that a multidistrict litigation (MDL) be established to consolidate all federal Invokana lawsuits into a single jurisdiction for pretrial handling. Earlier this month, a plaintiff from New York filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all such complaints in the U.S. District Court of New Jersey (In Re: Invokana [Canagliflozin] Products Liability Litigation, MDL Docket No. n/a, JPMDL). A similar request has also been made by plaintiffs in Philadelphia, suggesting a mass tort program.

FDA Strengthens Invokana Kidney Injury Warning

June 14, 2016 – Labels of the SGLT2 inhibitor diabetes drugs canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) have been changed to include a warning about an increased risk of acute kidney injury, according to an FDA Drug Safety Communication issued today. The upgraded warning follows reports of at least 101 confirmable cases of acute kidney injury, some of which required hospitalization and dialysis treatment, in patients treated with SGLT2 inhibitors between March 2013 and October 2015.

Invokana May Double Risk of Amputations, FDA Warns

May 18, 2016 – Canagliflozin, the active ingredient in Invokana, has been linked to a doubled risk of leg and foot amputations, according to an FDA Safety Alert issued today. The warning followed preliminary data from the CANVAS clinical trial which found that 7 in 1,000 patients on Invokana (100-mg/day) had amputations, compared to 3 in 1,000 on a placebo.

Canadian Invokana Lawsuit Seeks Class-Action Status, $1B in Damages

March 21, 2016 – A lawsuit filed last year in Canada seeks $1 billion in damages against Janssen Pharmaceuticals for injuries allegedly caused by Invokana, as well as class-action status from the Ontario Superior Court of Justice. Plaintiff in the case claims she started taking Invokana to treat the symptoms of her type 2 diabetes in 2014, and was subsequently diagnosed with kidney failure after watching an American TV commercial that warned about the side effect. The complaint alleges that Janssen did not conduct sufficient long-term studies on Invokana prior to brining the drug to market, and failed to adequately warn of its potential health risks.

EMA Warns of Ketoacidosis Risk with Invokana

February 11, 2016 – The European Medicines Agency (EMA) has linked Invokana and other SGLT2 inhibitor diabetes medications to over 100 cases of ketoacidosis. “Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports, blood sugar levels were only moderately increased,” the warning stated. “These uncharacteristic blood levels could delay diagnosis and treatment.” The agency is reviewing all available data on the ketoacidosis risk with SGLT2 inhibitors, and will consider whether any changes are needed in the way the drugs are used in the European Union (EU).

Tennessee Man Claims Kidney Failure from Invokana

February 9, 2016 – A Tennessee man has filed a product liability lawsuit (PDF) against Janssen, J&J and Mitsubishi Tanabe alleging the companies failed to adequately warn that Invokana may increase the risk of kidney failure. Plaintiff Wardell Fleming claims the drug caused him to suffer kidney damage and reduced kidney function, ultimately leading to full-blown kidney failure, and that he is now at an increased risk of heart attack, stroke, diabetic ketoacidosis (DKA) and other serious side effects as a result of his use of the drug. Fleming is suing for damages in excess of $5 million.

Has There Been a Recall?

None of the above SGLT2 inhibitors have yet been recalled, and these drugs continue to be prescribed to unsuspecting diabetics around the country. However, the investigation into the potential health problems caused by the medications is still in its early stages, and it often takes years for all the facts to come out that could eventually lead to a recall.

Invokana Settlement Information

Some lawsuits settle early in the claims process, but this is not expected in the Invokana litigation. The claims will likely either be handled individually or transferred to a multidistrict litigation (MDL). In either case, after a certain period of time initial trials (known as bellwether trials) will take place.
The purpose of bellwether trials is for the parties to get an idea of the types of evidence and arguments that will be made, as well as to see how juries will respond. After the bellwether trials have concluded, the parties are in a better position to determine whether a case can be settled or not. It is expected that Invokana settlements will follow this pattern, although the outcome of any case is never guaranteed and past results cannot provide an accurate representation of future outcomes.

Lawsuit Allegations

Complaints raised in Invokana lawsuits allege that the manufacturers failed to warn patients and physicians of diabetic ketoacidosis (DKA) and other serious side effects that the drug may cause. The complaints further state that had the manufacturer properly warned of these risks, patients would have been prescribed a different drug for their type 2 diabetes, and would have had their health monitored more closely for signs of potential health problems.

Has a Class Action Been Filed?

There is currently no class action lawsuit pending in the Invokana litigation. Instead, the law offices of Schmidt & Clark, LLP, are accepting individual claims on behalf of people who were injured by the drug. If we determine that you have a valid claim, you may be eligibile to receive compensation to assist with medical expenses, lost wages, pain and suffering, and more.

Is There a Time Limit to File a Claim?

Yes. Each state has its own specific statute of limitations (SOL) regarding the time frame a lawsuit can be filed in. If the suit is not filed before the designated SOL ends, the injured persons will be unable to file a complaint seeking compensation for damages. If you’ve been injured by Invokana, you should contact our lawyers now to protect your legal rights.

Do I Have an Invokana Lawsuit?

The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokana lawsuits. We are handling individual litigation nationwide and currently accepting new ketoacidosis cases in all 50 states.

Free Confidential Case Evaluation: Again, if you or a loved one has been injured by the side effects of Invokana, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.

FREE Confidential Case Evaluation

To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 223-3784.

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