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.
Joe Lyon is a highly-rated Ohio product liability attorney and Ohio Invokana lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims against pharmaceutical companies.
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
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.