Diabetic Medication Linked To Fournier’s Gangrene, Amputation
Do you qualify for an Invokana lawsuit? Millions of Americans with type-2 diabetes were prescribed Invokana, a drug that puts them at an increased risk of toe, foot, and leg amputation, as well as kidney injuries such as diabetic ketoacidosis.
The Invokana Lawsuit
Currently, there are hundreds of lawsuits awaiting trial against Invokana in both federal and state courts. Plaintiffs argue that Janssen Pharmaceuticals (which is a subsidiary of Johnson & Johnson) misrepresented the risks associated with Invokana and failed to warn doctors and patients about the medication’s side effects.
The lawsuit argues the following:
- Invokana is defective and unreasonably dangerous.
- Johnson & Johnson was negligent in the manufacturing of the drug.
- The company failed to test the medication correctly, and was unable to warn of the increased risks of kidney failure, ketoacidosis, and amputations.
- Johnson & Johnson concealed evidence of the dangers from the government and the public and misrepresented the safety of the drug in its marketing materials.
If you have suffered an injury caused by Invokana, you may be entitled to compensation. The Invokana lawsuit attorneys at The Carlson Law Firm have been representing clients injured due to pharmaceutical company negligence for over 40 years. Contact us today for a free legal consultation.
What Is Invokana?
Invokana, a Sodium-glucose cotransporter-2 (SGLT2), is an FDA-approved medication that works in conjunction with the kidneys to help a patient lose sugar through the urination process.
Product labels state that the medication is beneficial for the following reasons:
- It significantly lowers blood sugar
- It can help a person lose weight
- One pill works around the clock
- Most people taking this medication reached blood sugar levels (A1C) of less than 7.0
FDA Warnings About Invokana
In May 2015, the FDA warned that SGLT2 inhibitors like Invokana may lead to Diabetic Ketoacidosis (DKA). DKA is a condition where the body produces high levels of ketones (blood acids) that causes the blood to become overly acidic. According to the FDA, it has reviewed dozens of adverse event reports from patients who took these drugs and required hospitalization.
In September 2015, the FDA revised the labels of Invokana to include information about bone fracture risk and decreased bone mineral density. The updated warning was issued after the publication of a post-marketing study the FDA ordered Janssen to conduct when Invokana was approved.
The FDA added a warning about SGLT2 kidney side effects in June 2016. The warning was based on more than 100 adverse event reports submitted to the FDA. At the time, the agency noted that renal (kidney) side effects are probably underreported and may be more common than their limited records indicate.
In May 2017, the FDA ordered a black box warning (the highest warning it can issue) for the risk of toe, foot, and leg amputations. The warning was based on the results of two clinical trials which showed that patients with type 2 diabetes were twice as likely to need an amputation if they took Invokana than if they took a placebo.
Invokana and Fournier’s Gangrene
Fournier’s gangrene, also known as necrotizing fasciitis, is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the genital, perianal and perineal areas of the male body. Fournier’s gangrene can be caused by SGLT2 inhibitors used to treat diabetes.
SGLT2 inhibitors included:
- Invokana and Invokamet
- Farxiga (far-zee-ga)
- Xigduo XR (zig-doo-oh)
- Synjardy and Synjardy XR
The bacteria usually get into the body through a cut or break in the skin, where they quickly spread and destroy the tissue they infect.
If you or a loved one has suffered Fournier’s gangrene or other serious side effects after taking a diabetes drug with an SGLT2 inhibitor, you may be owed financial compensation from the negligent manufacturers. It is the responsibility of pharmaceutical corporations to ensure that drugs are safe, thoroughly tested, and clearly labeled with any warnings so that patients are not exposed to unnecessary health risks. When drug makers fail to fulfill their duties, they should be liable for the pain and suffering, medical expenses, and other damages that they have inflicted.
FDA Issues Warnings on Fournier’s Gangrene & Diabetes Infection
In August 2018, the U.S. Food and Drug Administration issued a warning communication to physicians and patients with type 2 diabetes alerting them that some patients who were treated with SGLT2 inhibitors developed an extremely rare and potentially deadly flesh-eating bacterial infection that destroys and decays the tissue in the perianal, perineal, and genital areas of the body. Complications of this condition, called necrotizing fasciitis of the perineum or Fournier’s gangrene, may include sepsis, acute renal failure, and multi-organ failure. The condition has a high mortality rate and patients who develop symptoms should seek medical attention immediately.
Invokana and Amputations
The popular diabetes medication Invokana has been linked to these amputation risks:
- Toe amputation
- Foot amputation
- Leg amputation
Clinical trials have found that patients taking Invokana are twice as likely to suffer a leg or foot amputation as those taking a placebo. Toe amputations and those in the middle of the foot are most common. Individuals taking Invokana should be especially careful to look for signs of increased tenderness, sores, ulcers, and infections in their legs and feet; and to immediately notify their doctors if such symptoms appear.
Invokana and Kidney Failure
Kidneys help filter waste products from the blood and help to control blood pressure, electrolyte balance, and red blood cell production. When your kidneys stop functioning properly, waste products, fluids, and electrolytes build up in the body and can cause weakness, shortness of breath, lethargy, confusion, abnormal heart rhythms and sudden death. Kidney failure occurs when your kidneys have stopped working well enough for you to survive without dialysis or a kidney treatment.
Invokana works to lower blood sugar by encouraging the kidneys to release excess sugar through the urine into the bladder. When sugar is present in the urine, the chance of developing a urinary tract infection is increased. Severe urinary tract infections may spread into the bloodstream and may damage the kidneys. Invokana may increase the chance of severe urinary tract infection and may increase the risk of kidney failure.
Symptoms of urinary tract infection usually include pain upon urination, urinary urgency, and urine that smells but it may progress quickly to a severe infection because Invokana increases the amount of sugar in the urine. More advanced symptoms may include flank pain (sides of lower back), fever, swelling and flu-like symptoms. Any unusual symptoms should be reported to a physician.
Other adverse renal functions associated with Invokana can include:
- Kidney impairment
- Dehydration/fluid imbalances
- Kidney stones
- Urinary tract infections
- Abnormal weight loss
Invokana and Diabetic Ketoacidosis
Diabetic Ketoacidosis is a life-threatening medical condition that occurs when cells in the body are unable to get the sugar they need for energy due to a lack of insulin. Insulin plays a significant role in helping sugar (glucose) enter cells, and provides needed energy to the muscles and other tissues. Without enough insulin, the body breaks down fat as an alternative source of energy, which causes a buildup of toxic acids in the bloodstream called ketones. Excess ketones result in ketoacidosis if untreated. Diabetic Ketoacidosis can occur in a patient suffering from a diabetic coma, extended hospitalization, and even death.
Symptoms of diabetic ketoacidosis, as noted by the American Diabetes Association, include:
- Trouble breathing
- Abdominal pain
- Confusion or difficulty concentrating
- Unusual fatigue or sleepiness
- Dry or flushed skin
Drugs That May Cause Diabetic Ketoacidosis
The following SGLT2 inhibitors may cause diabetic ketoacidosis and other dangerous side effects:
- Invokana (canagliflozin)
- Invokamet (canagliflozin/metformin)
- Jardiance (empagliflozin)
- Xigduo XR (dapagliflozin/metformin)
- Farxiga (dapagliflozin)
- Glyxambi (empagliflozin/linagliptin)
Invokana Lawsuit Eligibility
To be eligible for an Invokana lawsuit, a person must have taken Invokana (or a similar drug) and suffered ketoacidosis, kidney injury, or another type of unforeseen injury. The death of a patient who is taking an SGLT2 inhibitor may also be cause for legal action.
What Does An Invokana Lawsuit Cost?
Consultations at The Carlson Law Firm are free and confidential. If you decide to hire The Carlson Law Firm for your Invokana lawsuit, we will never charge you any fees or costs, unless you first recover, as we work on a contingency fee basis.
Recent Invokana Lawsuit News
September 1, 2018 – Certain medications used to treat diabetes have been linked to cases of a rare, potentially deadly flesh-eating genital infection, the Food and Drug Administration announced this week.
The medications affected: sodium-glucose cotransporter-2 (SGLT2) inhibitors, which are used in the treatment of type 2 diabetes. A release from the FDA lists more than a dozen drugs that will have to warn of the infection. Among the brand names listed: Invokana, Farxiga, and Jardiance.
New Lawsuit Accuses Johnson & Johnson, Janssen Pharmaceuticals of Failure to Adequately Research Invokana and Failure to Warn of Health Risks
July 13, 2017 – In an Invokana lawsuit filed July 3, 2017, plaintiff Martha Williams of Tennessee accuses Janssen Pharmaceuticals and parent company Johnson & Johnson of failure to adequately research all potential health risks of its new generation diabetes drug Invokana as well as failure to warn the public and medical community of such risks. The lawsuit blames an onset of acute renal failure, a urinary tract infection, dehydration and hypokalemia suffered by Williams just one month after starting the medication.
“Consumers of Invokana and their physicians relied on the Defendants’ false representations and were misled as to the drug’s safety, and as a result have suffered injuries including diabetic ketoacidosis, kidney failure, sepsis, cardiovascular problems, stroke, and the life-threatening complications thereof,” the lawsuit states. “The development of Plaintiff’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana.”
Read the entire complaint here.
United States District Court, District of New Jersey, Case 3:17-cv-4891
Invokana Linked to Amputations of the Toe, Foot, Leg
May 16, 2017 – The U.S. Food & Drug Administration (FDA) has issued an update citing clinical trials that found an increased risk of amputation in diabetes type two patients taking canagliflozin (Invokana, Invokamet), most involving the legs and feet.
The safety announcement states: “Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type two diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.”
They advise that anyone taking the medication consult with their doctor immediately should they experience any pain or tenderness, sores, ulcers or infections in the lower limbs. They do not recommend stopping the medication without first consulting with a physician or other healthcare provider.
Healthcare professionals are advised to consider any factors that may predispose a patient to amputations before starting the medication, which may include issues such as:
- Any prior amputations
- Peripheral vascular disease
- Diabetic ulcers in the feet
The two clinical trials referenced in the FDA safety announcement include results from the Canagliflozin Cardiovascular Assessment Study (CANVAS) and A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (CANVAS-R). Both studies published findings that indicated “leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. The CANVAS trial showed that over a year’s time, the risk of amputation for patients in the trial was equivalent to:
- 9 out of every 1,000 patients treated with canagliflozin
- 8 out of every 1,000 patients treated with placebo
The CANVAS-R trial showed that over a year’s time, the risk of amputation for patients in the trial was equivalent to:
- 5 out of every 1,000 patients treated with canagliflozin
- 2 out of every 1,000 patients treated with placebo
Invokana Lawsuit Update: Invokana Heart Attack, Stroke
Cardiovascular side effects have been a concern since early on in the drug’s approval process. On January 10, 2013, Dr. Sidney Wolfe, of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, expressed reservation concerning clinical trial outcomes citing abnormalities in the number of red blood cells in proportion to plasma, or “hemoconcentration” in patients who were taking the drug.
The drug is in a class of SGLT2 inhibitors that flush blood glucose through urine. At the same time, increased urination can also increase the concentration of red blood cells to a level that causes thickening of the blood, possibly increasing the risk of blood clots, stroke, and heart attack.
Wolfe noted that within the clinical trial data canagliflozin showed to increase hematocrit more than another SGLT2 inhibitor, dapagliflozin. He estimated that 25% of patients taking the drug could suffer hemocontrations that he called “a very dangerous range.”
Why Choose The Carlson Law Firm For Your Invokana Lawsuit
The Carlson Law Firm and its Invokana attorneys have been holding big pharma responsible for injuring innocent victims by their defective drugs and devices for over 40 years. These companies are some of the largest, wealthiest and most influential corporate entities in the world, which is why it is important that you have a skilled and knowledgeable team on your side. At The Carlson Law Firm, we’ve got your back.
If you have suffered harm due to any medical devices or medications, such as Invokana, it is essential that you retain experienced legal advocacy right away. We promise to provide victims with quality representation. When you call our firm, we take the time to understand the details of your case to be able to help you pursue financial compensation for injuries and losses.
These Invokana lawsuit cases are time-sensitive, so it is important to speak with an amputation lawsuit expert as soon as possible, as you may be entitled to compensation.
Contact an Invokana attorney The Carlson Law Firm today for your free consultation. We represent clients across the nation.