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:
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.
