Where you injured by Invokana or Invokamet?
You may be able to file an Invokana lawsuit if you or someone you care about experienced any of the following complications and side effects potentially related to canagliflozin, the active ingredient in both of these Type 2 diabetes treatments:
- Diabetic ketoacidosis
- Kidney damage
- Heart attack
- Toe and other lower limb amputations
Hundreds of Invokana and Invokamet lawsuits have already been filed in courts around the U.S., all of which accuse Johnson & Johnson and its Janssen Pharmaceuticals subsidiary of failing to provide doctors and patients with adequate warnings regarding the risks associated with these drugs.
The nationwide law firm of Bernstein Liebhard LLP is offering free, no-obligation case reviews to individuals who may have been injured by Invokana or Invokamet. To contact an experienced Invokana lawyer today, please call 1-877-779-1414.
Invokana and Invokamet
Invokana (canagliflozin) was introduced in March 2013, and was the first SGLT2 inhibitor to be granted regulatory approval by the U.S. Food & Drug Administration (FDA).
Janssen Pharmaceuticals brought Invokamet (canagliflozin and metformin) to market in November 2014.
SGLT2 inhibitors lower blood glucose levels by encouraging the kidneys to absorb more sugar, thus allowing for its elimination via urine.
In 2015, global sales of Invokana and Invokamet totaled more than $1.3 billion.
Invokana and Diabetic Ketoacidosis
In May 2015, the FDA disclosed that it was investigating a possible association between SGLT2 inhibitors and a potentially life-threatening complication called diabetics ketoacidosis.
According to the agency, more than 20 reports of diabetic ketoacidosis (DKA, ketoacidosis or ketosis) possibly related to the use of SGLT2 inhibitors had been reported to the FDA adverse event database from March 2013 to June 6, 2014. In all cases, patients required emergency medical care and/or hospitalization to treat the condition.
The following December, the FDA ordered that new warnings be added to the labels for all SGLT2 Inhibitor medications regarding the potential for diabetic ketoacidosis. The agency acted after a further review of its adverse event database identified 73 cases of ketoacidosis among patients treated with SGLT2 inhibitors from March 2013 to May 2015.
Two-thirds of those cases – 48 – occurred in patients treated with canagliflozin.
Diabetic ketoacidosis is condition that occurs when toxic acids called ketones accumulate in the blood. Untreated, the condition can lead to diabetic coma or even death.
Symptoms of Ketoacidosis include:
- Abdominal pain
- Trouble breathing
Invokana and Kidney Damage
In December 2015, the FDA also ordered the manufacturers of all SGLT2 inhibitors to update their labels with warnings regarding serious urinary tract infections that can progress to serious kidney infections.
The FDA acted after a review of its adverse event database identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections among patients taking SGLT2 inhibitors.
All of the incidents occurred between March 2013 through October 2014, and all 19 patients were hospitalized. A few were admitted to the ICU or underwent dialysis to treat kidney failure.
In June 2016, the FDA strengthened existing kidney warnings for canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR), after the SGLT2 inhibitors were tied to 101 reports of acute kidney injury.
Invokana and Lower Limb Amputations
In May 2017, the FDA confirmed a link between the use of canagliflozin-containing medications and an increased risk of lower limb amputations.
“Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations,” the agency stated. “We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.”
The FDA advised patients to contact their doctors if they developed new pain or tenderness, sores or ulcers, or infections in the legs or feet, while using a canagliflozin product.
Factors that could increase a patient’s risk of lower limb amputations include prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
Invokana Heart Attacks & Strokes
Results of the CANVAS clinical trial have suggested that Invokana may increase a patients’ risk of heart attack and other cardiovascular events by nearly 7-fold during the first 30 days of use.
Months before Invokana was approved, the FDA convened an advisory panel to discuss the medication’s safety and possible side effects.
During the meeting, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, expressed concern that Invokana might place patients at an increased risk for thrombotic events. Among other things, he noted that some patients in Invokana clinical trials had demonstrated elevated hematocrit levels.
Higher levels of hematocrit indicate thicker blood, which can increase the likelihood of blood clots.
When the FDA approved Invokana in March 2013, it ordered Janssen to conduct seven post-market studies, including a clinical trial, to better assess its cardiovascular impacts.
Invokana Lawsuits Centralized in New Jersey Federal Court
In December 2016, the U.S. Judicial Panel on Multidistrict litigation centralized all federally-filed Invokana and Invokamet lawsuits in the U.S. District Court, District of New Jersey, so that the cases could undergo coordinated discovery and other pretrial proceedings.
Initially, just 56 lawsuits were transferred to the federal Invokana litigation in New Jersey. Nearly a year later, the proceeding had grown to include more than 700 cases.
Plaintiffs who have filed lawsuits over Invokana and Invokamet claim that Johnson & Johnson and Janssen Pharmaceuticals:
- Withheld information from the FDA
- Misrepresented the risks and benefits associated with canagliflozin
- Failed to conduct proper safety studies of the drug
- Failed to warn patients about the side effects associated with Invokana and Invokamet
Contact an Invokana Lawyer Today
Individuals who suffered side effects allegedly associated with Invokana or Invokamet may be entitled to compensation for.
- Medical Bills
- Lost Wages
- Pain & Suffering
- Emotional Distress
- Wrongful Death
Our experienced Invokana lawyers will evaluate your case for free and fully explain all of your legal rights and options. To learn more about filing an Invokana lawsuit, please call our office as soon as possible at 1-877-779-1414.