Type 2 diabetes accounts for more than 90% of diabetes cases diagnosed in the United States, and many patients suffering from Type 2 diabetes take a new generation of prescription medications called SGLT2 inhibitors. However, mounting evidence has indicated that Type 2 diabetes patients who take SGLT2 drugs like Invokana may have an increased risk of experiencing severe side effects like amputations, diabetic ketoacidosis, heart attack and kidney failure. In fact, the FDA warns that leg and foot amputations occur about twice as often in individuals taking Invokana, compared to individuals not taking the diabetes drug. If you believe you have been adversely affected by side effects of Invokana or another Type 2 diabetes medication, consult an experienced Invokana attorney to discuss your legal options. With a qualified drug injury lawyer on your side, you can ensure that your legal rights are protected and pursue the financial compensation you deserve for your injuries and medical expenses.
There are a number of possible treatments for Type 2 diabetes, including prescription medications like Invokana and other SGLT2 inhibitors, alternative medicines and natural remedies. As concerns continue to mount regarding the potential side effects of Invokana and other prescription diabetes drugs, patients diagnosed with Type 2 diabetes may consider asking their doctor about other possible treatment options. In addition to making lifestyle changes related to diet and exercise, patients may try alternative diabetes treatments like:
Invokana (canagliflozin) belongs to a class of Type 2 diabetes medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which are designed to be used in combination with diet and exercise to lower blood glucose levels in adults with Type 2 diabetes. The prescription medication, approved by the U.S. Food and Drug Administration (FDA) in March 2013, functions by working with the kidneys to help excrete glucose through the process of urination, and is currently manufactured by Johnson & Johnson’s Janssen Pharmaceuticals unit. Although Invokana has only been on the market in the United States for a short time, the diabetes drug has already been linked to a potential risk of devastating side effects, including diabetic ketoacidosis (DKA).
Since it first entered the market, Invokana has been aggressively marketed by Johnson & Johnson and Janssen Pharmceuticals as a safe and effective treatment for Type 2 diabetes. However, recent reports have suggested that diabetes patients taking SGLT2 inhibitors like Invokana may face an increased risk of serious medical complications that could potentially lead to death. Among the side effects allegedly linked to Invokana and other SGLT2 medications, like Invokamet (canagliflozin/metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin/metformin), Glyxambi (empagliflozin/linagliptin) and Jardiance (empagliflozin), are:
Diabetic ketoacidosis, a subset of ketoacidosis or ketosis in diabetes patients, is a serious medical condition that occurs when the body produces high levels of ketones, or toxic acids in the bloodstream, which can lead to diabetic coma and death. According to reports, DKA typically develops in patients with Type 1 diabetes who also have high blood sugar levels. However, instances of diabetic ketoacidosis have been reported in patients with Type 2 diabetes who have only slightly increased blood sugar levels, when compared to typical cases of DKA, and this phenomenon is believed to be linked to the use of SGLT2 inhibitors like Invokana.
The first indication that Invokana treatment could put users at risk for serious side effects came in May 2015, following a search of the FDA’s Adverse Event Reporting System, which identified 20 instances of acidosis reported as diabetic ketoacidosis, ketoacidosis or ketosis in diabetes patients taking SGLT2 inhibitors like Invokana between March 2013 and June 6, 2014. According to the adverse event reports, all 20 cases included an emergency room visit or hospitalization in order for the patient to receive treatment for the ketoacidosis, and the FDA has indicated that the agency continues to receive reports of DKA side effects in Invokana patients.
The same month that the FDA issued its Invokana warning, the Institute for Safe Medication Practices (ISMP) released its own independent report based on adverse events submitted to the FDA, in which it highlighted the risk of kidney toxicity from the SGLT2 inhibitor. During the first year Invokana was on the market, the ISMP identified 457 serious adverse events reported to the FDA involving side effects of Invokana, and since these reports typically only account for a small percentage of the problem as a whole, it is likely that the risk of diabetic ketoacidosis, kidney failure and heart attack associated with Invokana treatment is significantly higher than originally believed.
As more information comes to light about the alleged risk of diabetic ketoacidosis and other devastating side effects from Invokana, product liability lawsuits are expected to be brought against Johnson & Johnson and Janssen Pharmaceuticals, on behalf of consumers who believe they have been harmed by the Type 2 diabetes drug.
May 2015 – A drug safety communication issued by the FDA highlights numerous reports of ketoacidosis and diabetic ketoacidosis requiring hospitalization in patients taking Invokana.
September 2015 – The FDA revises the Invokana label to include updates on the risk of bone fractures associated with the drug, as well as new information about the risk of decreased bone mineral density from Invokana treatment.
December 2015 – All manufacturers of SGLT-2 inhibitors are required to revise their warning labels to include warnings about ketoacidosis. The FDA also reveals at this time, that it has received 19 reports of life-threatening blood infections and kidney infections in Invokana users, all requiring hospitalization.
May 2016 – The FDA alerts consumers and healthcare providers about interim safety results from an ongoing clinical trial that found a high rate of leg and foot amputations among Invokana users.
June 2016 – The FDA strengthens its warning about the risk of acute kidney injury for Invokana users, reporting that between March 2013 and October 2015, the agency received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, associated with Invokana or Farxiga.
February 2017 – The European Medicines Agency (EMA) extends the label warning about amputations to other drugs in the SGLT-2 inhibitor class, but the FDA has yet to do so.
May 2017 – Based on data from two large clinical trials, the FDA issues a safety announcement warning that Invokana causes an approximately two-times increased risk of foot and leg amputations. The agency requires a new black-box warning to be added to the Invokana label highlighting this risk.
July 2017 – The risk of amputations is finally addressed in Invokana labeling.
February 2017 – The Canagliflozin Cardiovascular Assessment Study (CANVAS) and CANVAS-R clinical trials, designed to assess the cardiovascular risk for patients with Type 2 diabetes taking Invokana, find that, while the drug reduces heart problems in participants, it also nearly doubles the risk of lower-extremity amputations.
July 2017 – An analysis of safety reports from the FDA’s adverse event reporting system (FAERS), published online in Lancet Diabetes & Endocrinology, reports that, of 66 reports of amputations associated with the SGLT-2 inhibitor class of drugs, 57 (86%) involved Invokana. The report also notes that two-thirds of the amputations occurred among patients with no discernible risk factors for amputation.
Concerns continue to mount over the alleged side effects of Invokana, and critics have indicated that red flags were raised about the potential risks of the Type 2 diabetes medication before it was even approved by the FDA. According to a review of information taken into consideration by the FDA’s Endocrinologic and Metabolic Drug Advisory Committee prior to Invokana’s approval in 2013, the potential risk of heart problems and strokes from Invokana was brought to light before the SGLT2 inhibitor entered the market. Based on these findings, and recent warnings about the potential risk of lower limb amputations associated with Invokana treatment, serious doubts have been raised about whether the minimal benefits offered by Invokana treatment justify the potential risks, and any Invokana lawsuits filed in the future over side effects like amputations and diabetic ketoacidosis may allege the following:
In light of the potential for Invokana and other SGLT2 inhibitors to cause lower limb amputations and other severe side effects in users, the FDA has advised healthcare professionals to be aware of the factors that may predispose certain patients to amputation, and recommends that patients to be aware of any new pain or tenderness, sores or ulcers, or infections in the legs or feet, which may indicate problems that could lead to amputation. In regards to the risk of diabetic ketoacidosis associated with SGLT-2 inhibitors, the FDA says that patients should stop taking Invokana and seek medical attention immediately if they exhibit any symptoms of ketoacidosis. If you took Invokana or another SGLT2 inhibitor in the past, and you have since suffered a potentially life-threatening side effect like diabetic ketoacidosis or required one or multiple amputations, contact a knowledgeable Invokana lawyer today for legal help. You may be entitled to financial compensation for your injuries, which you can pursue by filing an Invokana claim against Janssen Pharmaceuticals.