Invokana (generic name: Canagliflozin) is a modern medication for people living with type 2 diabetes. Developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, this medication is designed to help reduce blood sugar levels. However, recent reports indicate that patients taking Invokana suffer from an increased risk of below-the-knee amputations. Patients taking Invokamet and Invokamet XR are also at risk.
Here’s the latest information about the risks of taking Invokana, including how this drug works, clinical trial information, FDA warnings about canagliflozin, and what to do if you have had a limb amputated as a result of taking this potentially dangerous drug.
How Invokana and SGLT-2 Inhibitor Drugs Work
Canagliflozin is the active ingredient in the drug Invokana. Canagliflozin may also be found in combination with metformin, in a drug called Invokamet or Invokamet XR, an extended release formula.
Invokana is classified as a gliflozin drug. Invokana and other gliflozins work by affecting protein in the kidneys called sodium glucose transport protein 2 (SGLT-2). Normally, the body filters blood sugar (glucose) into urine but reabsorbs it back into the body before it can be excreted. By inhibiting the SGLT-2 protein, Invokana prevents some blood sugar from being reabsorbed from the urine back into the body, letting the patient get rid of excess blood sugar by urinating.
FDA Invokana Safety Warnings After Clinical Trials
The Food and Drug Administration (FDA) has determined that drugs containing Canagliflozin pose a special health risk and must carry a black box warning label warning of the increased chances for foot and leg amputations. This decision comes based on the outcome of two clinical studies involving Canagliflozin.
The Canagliflozin Cardiovascular Assessment Study (CANVAS) was a major study involving over 10,000 participants with type 2 diabetes. This study found that the risk of amputation for participants taking Canagliflozin more than doubled compared to the placebo group, from 2.9 per 1,000 participants in the placebo group to 5.8 per 1,000 participants taking Canagliflozin.
A second study called “A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus” (CANVAS-R) found similar results, with nearly double the risk of amputations. Around 7.5 out of every 1,000 patients taking Canagliflozin required amputations, versus only 4.2 out of every 1,000 taking placebo medication.
The studies found that the most common amputations were of the toe and middle of the foot. Amputations either below or above the knee, or multiple amputations on one or both legs, were sometimes necessary, as well.
Effects of FDA Invokana Warning
With this new safety notice in effect, many patients may have made the choice not to take Invokana had they known about the potential side effects early on. Many of these patients who have suffered amputations, heart problems, and kidney failure as a result of this drug have filed lawsuits against Janssen Pharmaceuticals and Johnson & Johnson, alleging that the companies failed to adequately alert either doctors or patients of the health risks of Canagliflozin.
A multidistrict litigation (MDL) was formed in New Jersey and consists of nearly 1,000 patients who have suffered harm, with bellwether trials slated to begin in September 2018. Multiple additional patients have also filed suits at the state or federal level in California, New Jersey, Missouri, and Pennsylvania, seeking relief for Canagliflozin-related injuries.
Legal Help for Invokana Injuries
If you or someone you love has suffered from an amputation, cardiovascular issue, kidney problems, diabetic ketoacidosis, or other health problems as a result of taking Invokana, Invokamet, or Invokamet XR, you may be able to seek compensation in a court of law. You could be eligible to receive a financial award for your hospital bills and future medical expenses, lost wages, diminished earning capacity, pain and suffering, and more. A personal injury attorney can advise you of your rights and help you decide what your best legal options are.
Wayne Wright LLP has been helping patients who have been harmed by dangerous drugs from greedy pharmaceutical companies for decades, and we’d like to help your family seek the justice that you deserve. To arrange a free, no-obligation consultation with an experienced legal professional at Wayne Wright LLP, call us today, use our contact form to send an email, or click the live chat box on this page right now.