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Invokamet Lawsuit

Invokamet Lawsuit

Lawsuits have been filed by people who developed diabetic ketoacidosis (DKA) or kidney failure after taking Invokamet. The FDA has issued warnings about additional risks like amputations, bone fractures, infections, and more.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Invokamet induced injury cases in all 50 states. If you or somebody you know was diagnosed with a severe side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

UPDATE: Invokamet Linked to Genital Infections

In August 2018, the FDA issued a Safety Communication after 1 person died and 11 others were hospitalized with a severe genital infection called necrotizing fasciitis of the perineum (Fournier’s gangrene) after taking diabetes drugs in the SGLT2 inhibitor class.

What is Invokamet?

Invokamet is two medicines in one pill. It combines canagliflozin (Invokana) with metformin. Invokamet is made by Janssen Pharmaceuticals and is approved by the FDA for the treatment of type-2 diabetes. In September 2016, the FDA approved Invokamet XR, an extended-release version of Invokamet.

What is the problem?

One of the most serious side effects of metformin is lactic acidosis (a build-up of lactic acid in the blood). The FDA has also issued warnings about the following severe side effects:

FDA: Invokamet Doubles Risk of Amputations

In May 2016, the FDA began investigating a clinical trial linking Invokamet to a doubled risk of leg, foot, and toe amputations. The problem is that Invokamet often causes dehydration, which exacerbates circulation problems in the lower legs. Click here to read more.

FDA Adds ‘Black Box’ Warning for Invokana Amputation Risk

In May 2017, the FDA ordered drug-makers to add a “Black Box” label to warn patients that Invokana doubles a patient’s risk of leg and foot amputations. The risk is about 7 in 1,000 patients on Invokana, but it may be higher for patients with risk-factors for diabetic foot disease.

FDA Safety Warning: Ketoacidosis

Invokamet belongs to a class of diabetes medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. It works by helping the kidneys remove sugar from the body by excreting it in urine.

In May 2015, the FDA issued a Safety Communication to announce that they had received nearly two dozen reports of patients on SGLT2 inhibitors who were hospitalized with diabetic ketoacidosis between March 2013 and June 2014. In December 2015, the FDA updated the label on Invokana to include ketoacidosis. If you are taking Invokana, the FDA recommends:

Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones.  Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.

New Diabetes Drugs Linked to 101 Cases of Ketoacidosis Worldwide

The European Medicines Agency (EMA) has issued a warning for SLGT2 inhibitor diabetes drugs after receiving 101 reports of diabetic ketoacidosis as of May 19. All of the cases were serious. Some patients had to be hospitalized. The EMA warns, “Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased. These uncharacteristic blood levels could delay diagnosis and treatment.”

What is Ketoacidosis?

Ketoacidosis occurs when your body starts burning fat instead of using glucose (sugar) from the bloodstream. This causes acidic waste products known as ketones to build up in the blood and urine. Many cases require hospitalization. Without treatment, the victim can fall into a coma and die.

Warning Signs of Diabetic Ketoacidosis

The first warning signs of diabetic ketoacidosis typically include:

  • Thirst or dry mouth
  • Frequent urination
  • High blood-sugar levels
  • High levels of ketones in urine

Without treatment, later symptoms may include:

  • Constantly feeling tired
  • Dry or flushed skin
  • Nausea, vomiting
  • Abdominal pain
  • Breathing problems
  • Fruity-smelling breath
  • Trouble concentrating
  • And more

FDA Warning: Invokamet and Kidney Injury

In June 2016, the FDA strengthened warnings about acute kidney injury from Invokana, Invokamet, Farxiga, and Xigduo XR. The agency received 101 confirmed cases of acute kidney injury from March 2013, when Invokana was approved, until October 2015.

Common Medications Increase Risk of Kidney Injury

Risk-factors for acute kidney injury include dehydration, decreased blood volume, chronic kidney insufficiency, congestive heart failure. Medications like diuretics, blood pressure drugs (ARBs and ACE inhibitors), and NSAID painkillers like ibuprofen also increase the risk of kidney injury.

Invokamet Class Action Lawsuit

Our attorneys are nationally recognized in class action litigation, but we are not filing an Invokamet class action. Instead, we are filing individual lawsuits on behalf of people who were severely injured by side effects of Invokamet.

Invokamet Lawsuits Centralized in New Jersey MDL

In December 2016, a panel of federal judges centralized nearly 100 lawsuits involving side effects of Invokana and Invokamet into a Multi-District Litigation (MDL No. 2750). The litigation will be coordinated in the U.S. District Court for New Jersey under Judge Brian R. Martinotti — the same venue lawyers requested in a motion filed in September.

Do I have an Invokamet Lawsuit?

The Schmidt Firm, PLLC is currently accepting Invokamet induced injury cases in all 50 states. If you or somebody you know was diagnosed with a severe side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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