The type 2 diabetes drug Invokamet (generic: canagliflozin/metformin) has been linked to an increased risk for serious side effects including diabetic ketoacidosis (DKA), kidney failure, heart attack, bone fractures and amputations of the foot, leg and toes.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Invokamet, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: FDA Requires Boxed Warning on Amputation Risk with Invokamet
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 Invokamet?
Invokamet is a type 2 diabetes medication that combines canagliflozin and metformin. The drug is classified as a SGLT2 inhibitor, and works by:
- Helping to restore the body’s response to insulin;
- Increasing the removal of sugar by the kidneys;
- Decreasing how much sugar is made in the liver, and
- Decreasing how much sugar the body takes in through the stomach and intestines.
Invokamet was approved by the U.S. Food & Drug Administration (FDA) in August 2014.
Diabetes Medications Linked to Ketoacidosis: FDA Safety Alert
According to an FDA warning issued May 15, 2015, Invokamet and other diabetes drugs from the SGLT2 inhibitor class were linked to at least 20 cases of “diabetic ketoacidosis,” “ketoacidosis,” or “ketosis” from March 2013 to June 6, 2014. The agency said all affected patients required either hospitalization or a visit to the emergency room to treat the problem.
Since June 2014, FDA has continued to receive reports of ketoacidosis in patients treated with SGLT2 inhibitors. In addition to Invokamet, other diabetes medications in the SGLT2 inhibitor class include Farxiga, Xigduo XR, Invokana, Glyxambi and Jardiance. An ongoing investigation will determine whether the drugs’ prescribing information needs to be changed to include information about the ketoacidosis risk.
What is Diabetic Ketoacidosis?
Diabetic ketoacidosis (DKA) is an acute complication of diabetes. Although the condition is typically found in type 1 diabetes patients with high blood sugar levels, most of the cases reported to the FDA involved type 2 diabetics with only slightly raised blood glucose levels. Ketoacidosis is caused by low insulin levels in the blood, which forces body cells to burn fat instead of glucose for energy, resulting in the production of ketones.
Signs & Symptoms
Symptoms of ketoacidosis include:
- Difficulty breathing
- Abdominal pain
Invokamet Side Effects
In addition to being linked to diabetic ketoacidosis, Invokamet and other diabetes drugs from the SGLT2 inhibitor class have been linked to the following serious side effects:
- Heart Attack (Myocardial Infarction or MI)
- Amputations of the foot, leg or toes
- Kidney Failure (Renal Failure)
- Kidney Cancer
- Kidney Infections (Pyelonephritis)
- Kidney Stones
- Bone Fractures
- Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
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.
Invokamet 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.
FDA Upgrades Invokamet Kidney Failure Warning
June 14, 2016 – FDA has announced changes to the labeling of canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga and Xigduo XR) regarding an increased risk of acute kidney injury. The agency received at least 101 conformable reports of the condition — some requiring emergency hospitalization and dialysis treatment — associated with these medications between March 2013 and October 2015.
FDA Approves Expanded Use of Invokamet
May 24, 2016 – Janssen announced today that the FDA has approved Invokamet as a first-line treatment for adults with type 2 diabetes, according to Street Insider. With this expanded approval, Invokamet may now be prescribed to type 2 diabetes patients who are not already being treated with canagliflozin or metformin, and may benefit from dual therapy.
Invokamet Linked to Increased Amputation Risk, FDA Warns
May 18, 2016 – FDA issued a warning today regarding an increased risk of leg, foot and toe amputation with canagliflozin, the active ingredient in Invokamet. The alert follows an interim analysis of the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) trial, which determined the amputation risk as equivalent to:
- 7 out of every 1,000 patients treated daily with 100 mg canagliflozin;
- 5 out of every 1,000 patients treated daily with 300 mg canagliflozin, and
- 3 out of every 1,000 patients treated with placebo.
FDA Warns SGLT2 Inhibitors May Increase Bone Fracture Risk
September 10, 2015 – In a drug safety communication issued today, FDA announced that it had updated the labeling of Invokamet and Invokana 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. Click here to learn more.
Invokamet Settlement Information
Each year, thousands of Americans allege injuries from diabetes drugs like Invokamet. Many of these patients have filed lawsuits against manufacturers of the products they claim caused their injury.
Recently, thousands of lawsuits have resulted in substantial settlement awards to reimburse patients for past and future medical expenses, lost wages, and pain and suffering. Some families of people who have died after taking diabetes drugs have filed wrongful death claims and in some cases, manufacturers have also been required to pay additional penalties for intentional wrongdoing, known as punitive damages. To learn more about Invokana, its side effects and litigation, please visit our Invokamet FAQ page.
Do I Have an Invokamet Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokamet lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by the side effects of Invokamet (dapagliflozin), you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.