Invokana – Lower Limb Amputation
Type 2 diabetes is a medical condition affecting over 9% of the population or an estimated 28 million Americans. The most common drug to treat Type 2 diabetes is Invokana.
Manufactured by Johnson & Johnson, Invokana is the brand name of the drug canagliflozin, which is a sodium glucose cotransporter-2 (SGLT2) inhibitor. This class of Type 2 diabetes drugs lowers blood sugar by causing the kidneys to remove sugar from the body via urine.
The European Medicines Agency (EMA) and The FDA are warning that canagliflozin increases the risk of skin infections and ulcerations. These cuts cause such a horrible infection that doctors must amputate toes and other lower extremities.
Invokana & Lower Limb Amputation
The European Medicines Agency (EMA) and The FDA are warning that canagliflozin increases the risk of skin infections and ulcerations. The Canagliflozin Cardiovascular Assessment Study (CANVAS) has found that 7 out of 1,000 patients taking Invokana will need lower-limb amputation. This seems like a small number; however, it truly is massive when you consider that Invokana is the best-selling inhibitor drug on the market for Type 2 diabetes.
This means that hundreds of thousands of people who take Invokana are completely unaware that a seemingly innocent cut on a toe, may lead to amputation because of their Invokana use.
Black Box Warning
On May 16, 2017, the FDA issued a new Black Box warning for the Type 2 diabetes drug, Invokana, Invokamet and Invokamet XR. Due to new data from the clinical trials CANVAS and CANVAS –R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus), the FDA felt these medications deserved the most severe warning in regards to lower limb amputations.
In the CANVAS and CANVAS-R studies, researchers found a twofold risk of amputation compared to patients treated with a placebo. Amputations of the toe and middle of the foot were the most common, however; amputations involved the leg, below and above the knee also occurred. Some even had multiple amputations, which involved both limbs.
Lower Limb Amputation Symptoms
- Pain or tenderness
- Sores or ulcers
- Infections on legs or feet
Do not suddenly stop taking Invokana without speaking to your doctor first. Consequently, this could lead to uncontrolled blood sugar levels, blindness, nerve and kidney damage and heart disease.
According to the FDA, there were at least 20 cases of ketoacidosis associated with the class of SGLT2 inhibitors drug within 15 months. All these cases require visits to the emergency room or hospitalization.
But that’s nothing compared to 457 serious adverse events reported to the FDA between March 2013 and March 2014, as documented by the Institute for Safe Medication Practices.
This was higher than 92% of other medicines regularly checked. The report notes the “clear evidence of harm” Invokana reaches the kidneys.
When a clear evidence of harm exists, you deserve to be compensated.
Invokana manufacturer, Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has netted almost $1 billion in profits from Invokana in the last year alone. Meanwhile, the number of individuals injured by Invokana have begun to accumulate. They have begun to file consumer protection lawsuits against the pharmaceutical giant.
At the present time, The Michael Brady Lynch Firm is concentrating on Pennsylvania. This is the location where our cases are pending against the makers of Invokana. As of June 2016, plaintiffs filed approximately 41 cases in Philadelphia involving people living all across the country. This will most likely mean a mass tort consolidation at the Federal level is imminent.
When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury as a result of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect other people and their families from needless distress.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Therefore, if the conduct of a drug company in manufacturing and selling drug is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you had lower limb amputation after taking Invokana, please speak to us to learn more about your rights.
Case evaluations are free of cost and without obligation. Call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.