Pharmaceutical Defect Attorney and Ohio Invokana Lawyer Reviews Injuries: Kidney Failure, Fourniers Gangrene Infection & Amputations
Since May, 2017, two clinical studies have concluded that there is a link between the popular diabetes drug Invokana (canagliflozin) and an increased risk of lower limb amputations. Researchers have said the drug may double amputation risk in diabetes patients.
As a result, the U.S. Food and Drug Administration (FDA) has required Johnson & Johnson and Janssen Pharmaceuticals to revise and strengthen its Invokana warning. The FDA has advised doctors to discontinue Invokana for patients who experience serious pain or extremity infection and Fournier’s Gangrene.
Thus far in legal proceedings, thousands of personal injury claims have been filed against the drug manufacturers. Around 50 percent of reported amputations among patients were of toes—remaining amputations in patients were at the foot, ankle, below the knee and above the knee. Some patients have reported more than one amputation and severe Fourniers gangrene infection.
Prior to amputation risk concerns in 2017, Invokana use was already associated with kidney issues, ketoacidosis and serious cardiac events. Plaintiffs and attorneys claim the manufacturers, Johnson & Johnson failed to properly test the medication, failed to warn consumers of the risks, and may have even concealed evidence of some health hazards from the FDA during the approval process.
What is Invokana Used to Treat?
Invokana (Canagliflozin) is a drug primarily prescribed to patients with type 2 diabetes—and sometimes type 1—to help lower blood sugar levels. Canagliflozin is an SGLT-2 inhibitor (sodium-glucose cotransporter-2 inhibitor) which assists the kidneys to remove sugar from the body. Experts worry that similar drugs carry similar risks to patients. Other SLGT-2 inhibitors on the market in the same drug class include:
- Invokamet XR
- Xigduo XR
Invokana Injuries & Complications
Recent research shows an alarming rate of leg, foot and toe amputations, and has been hit with hundreds of adverse-event reports from the time the drug was released. Patients and medical professionals should monitor the following signs and symptoms of Invokana-related issues:
- Sores on legs
- Serious leg or foot pain
- Leg infection
- Low blood pressure
- High levels of potassium in the blood
- Urinary tract infections
- Low blood sugar when combined with other diabetes medicine
- Yeast infections
- Bone fractures
- Increased cholesterol
Serious complications from taking Invokana include the following:
- Amputation: patients taking Invokana are twice as likely to need a leg or foot amputation as those taking a placebo. Toe amputations are the most common. Patients taking Invokana should be vigilant and look for signs of increased tenderness, sores, ulcers, and infections in their lower extremities. Contact an Ohio Invokana Lawyer following any catastrophic drug injury.
- Ketoacidosis: Ketoacidosis is a condition where high levels of ketones (toxic acids) are produced in the body, resulting in diabetic comas, extended hospitalizations, and even death. Ketoacidosis develops when insufficient levels of insulin are produced within the body, and the body breaks down fat as an alternative source of energy.
- Kidney Failure: Kidney failure occurs when a person’s kidneys stop functioning without the use of dialysis or a transplant. Kidneys help filter waste products from the blood, and help to control blood pressure, electrolyte balance, and red blood cell production. When kidneys stop functioning properly, the result is general weakness, shortness of breath, confusion, and abnormal heart rhythms.
- Heart Attacks
- Fournier’s Gangrene Infection
Ohio Drug Injury Lawyer investigating diabetes drug complications and reviewing amputation and Invokana Fourniers Gangrene Lawsuit settlements for injured plaintiffs nationwide
Fournier’s gangrene is an acute necrotic infection of the scrotum, penis, or perineum, which presents in pain, redness and a dangerous rapid progression to life-threatening gangrene. Fournier gangrene typically follows other infections associated with SGLT diabetes drugs like Invokana, trauma, surgery infections, or urinary tract disease.
Fournier Gangrene is highly-associated with diabetic patients taking SGLT2 medications, long-term alcohol abuse and non‐obvious immune compromised patients. Many cases of Fournier’s Disease have been documented in adult males taking Invokana or other SGLT diabetes drugs that raise the risk of infection and amputations. The disease has been identified, even more rarely, in women and children.
Recent clinical trials have concluded that the use of the popular diabetes drug, Invokana (canagliflozin), may increase the risk of lower limb amputation. The drug is said to double amputation risk in diabetes patients.
Since May, 2017, when two clinical studies demonstrated a link between Invokana and an elevated risk of lower limb amputations, the U.S. Food and Drug Administration (FDA) has required Invokana to revise and strengthen its warning, and has advised prescribing doctors to discontinue Invokana for patients who experience unusual pain, sores or extremity infection.
As a result, thousands of injury claims have been filed against Johnson & Johnson and Janssen Pharmaceuticals by individual patients. About half of reported amputations among patients in the trial noted above were of toes. The remaining amputations were across the foot, at the ankle, below the knee and above the knee. Some patients have had more than one amputation, sometimes involving both limbs.
Prior to May, 2017, Invokana use was already linked to kidney damage, ketoacidosis and heart attack events. Lawyers claim the drug manufacturers failed to properly warn consumers of the dangers of Invokana gangrene infection injuries, failed to properly test the medication, and possibly concealed evidence of the dangers from regulatory bodies and the public.
Joe Lyon is an experienced Drug Injury Attorney reviewing cases of SGLT2 medication amputation and Invokana Fourniers Gangrene Lawsuit settlements for victims and plaintiffs.
Fournier’s Gangrene Symptoms
Symptoms of Fournier Disease include fever, general discomfort, pain and swelling in the genital areas and a smell of the affected tissues affected by gangrene. Affected gangrene tissue can extend to the thighs and abdomen. Fournier’s disease can be found in conjunction with other conditions that weaken the immune system, like diabetes mellitus, obesity, cirrhosis, and blood disorders.
A diagnosis is necessary to distinguish between Fournier Gangrene and another acute inflammatory condition like epididymitis or orchitis.
Invokana FDA Black Box Warning
The most recent FDA warning is more visible for patients, and goes further to suggest physicians carefully consider certain factors before prescribing the drug which may predispose patients to amputations, such as prior amputations, peripheral vascular disease, neuropathy and diabetic foot ulcers.
This 2017 warning is in addition to another in 2016 when the FDA strengthened a warning to users of canagliflozin for an increased risk of acute kidney injury. In 2015, the FDA warned that Invokana (canagliflozin) presents an increased risk of bone fractures.
Though the drug companies manufacturing Invokana are not as forthcoming, the FDA has been clear about the dangers and severe risks of the drug. They stress to all patients taking Invokana, Invokamet and Invokamet XR the importance of contacting their doctors immediately if they notice unusual pain, sores, ulcers or infections on their legs or feet.
Fournier Gangrene Classification
The disease is rare and has been called several variations, including:
- Fournier disease
- Fournier’s disease
- Fourniers disease
- Fournier’s gangrene
- Fourniers gangrene
- Necrotizing fasciitis of the perineum and genitalia
Fournier’s Gangrene Causes & Treatment
Bacteria, fungi, and viruses can each be responsible for a case of Fournier gangrene. Existing abscesses, infections, surgical intrusion and contributing SGLT2 diabetes drug factors may be related. Not everything about Fournier’s Gangrene is understood, though diabetes and drugs like Invokana appear to be of some association.
In the average patient, the mean age is about 50 years, and Fournier gangrene is diagnosed more frequently in males. Illnesses such as diabetes, alcoholism, HIV infection, and malnutrition will increase the risks, though how much is unknown.
Treatment involves broad-spectrum intravenous antibiotics followed by urgent surgical removal of all gangrene areas. Patients with a blood infection (sepsis) are at an increased risk for developing blood clots. Complications are likely and the outlook varies from patient to patient.
Invokana Fourniers Gangrene Lawsuit
The Lyon Firm specializes in drug injury cases and pharmaceutical defect lawsuits on behalf of injured patients nationwide. We work with industry experts to determine the root cause of injury. Contact medical professionals for healthcare and for legal assistance and to consider an Invokana Fourniers Gangrene Lawsuit, call an experienced attorney.
Invokana has been bogged down in adverse-event reports almost from the beginning. About one year after the drug gained FDA approval, the Institute for Safe Medication Practices issued a report indicating a link between kidney damage, Fourniers Gangrene, renal failure and SGLT2 inhibitors. The next year, the FDA issued a warning that it may also cause ketoacidosis. The FDA has warned of other side effects that may include:
• Low blood pressure
• High amounts of potassium in the blood
• Serious urinary tract infections
• Low blood sugar when combined with other diabetes medicine
• Yeast infections
• Bone fractures
• Increased cholesterol
Contact an Ohio Invokana Lawyer
Black Box Warning on Packaging: The FDA has warned of a serious Fournier’s Gangrene Infection Risk.
The 2017 FDA-approved packaging warning is made more visible for patients, and strengthens their previous amputation warning. The new black box warning suggests physicians consider certain factors before prescribing, which could predispose patients to amputations—prior amputations, peripheral vascular disease, neuropathy and foot ulcers are red flags to doctors and patients.
The warning also says doctors should consider discontinuing the use of the drug if infections and sores develop on patients’ lower extremities.
The FDA has been clear about the dangers and severe risks of the drug. The warnings may be too late, however, in many cases. Many patients have suffered injuries. Attorneys are filing claims, arguing the following:
- Invokana is defective and causing severe injuries
- Johnson & Johnson is negligent in the manufacturing of Invokana
- Johnson & Johnson failed to properly test the medication
- Johnson & Johnson failed to warn of increased risk of amputation, kidney failure and ketoacidosis
- Johnson & Johnson misrepresented the safety of the drug in marketing material.
If you or a loved one has suffered from Invokana injuries, and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, an Ohio Invokana Lawyer, and he will help you answer these critical questions.