Serious Injuries Linked to Invokana®, Farxiga®, Jardiance® and other SGLT2 Inhibitors

Increased Risk of Leg, Foot & Toe Amputations

In 2017 the FDA issued a Drug Safety Communication confirming that patients taking Invokana®, Invokamet® and Invokamet® XR are at an increased risk of leg and foot amputations and that the manufacturers (Johnson & Johnson and its subsidiary Janssen Pharmaceuticals) must include a “Black Box Warning” on the drugs’ labeling.

The Drug Safety Communication was issued after the FDA reviewed data from two different clinical trials – the CANVAS and CANVAS-R studies. These data demonstrated that diabetes patients treated with Invokana®, Invokamet® and Invokamet® XR were twice as likely to require leg and foot amputations than those diabetes patients who were taking placebo (a non-drug).

Amputations Per 1,000 Patients

In the two studies, amputations of the toe and middle foot were the most common (~ 70%) but both leg and below/above the knee amputations also occurred (30%). Some patients had more than one amputation and some had amputations involving both limbs.

Invokana’s® Black Boxed Warning – Amputation Risk

After reviewing data from the two clinical trials, the FDA required the addition of the following Boxed Warning to the labeling for Invokana®, Invokamet® and Invokamet® XR:

IMPORTANT SAFETY INFORMATION

INVOKANA® can cause important side effects, including:

• Amputations. INVOKANA® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your INVOKANA® for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care.

SGLT2 Inhibitors and Fournier’s Gangrene – A Potentially Fatal Flesh-Eating Genital Infection

On August 29, 2018 the FDA issued an urgent Safety Announcement to health care professionals and their patients. The Alert warned about the association between Invokana®/Invokamet®/Invokamet XR®, Jardiance®, Farxiga® and other SGLT2 diabetes medications and Fournier’s Gangrene, a life-threatening genital infection that can affect both men and women. Invokana®, Farxiga® and Jardiance® are included in the class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors which are prescribed for the treatment of Type 2 Diabetes.

SGLT2 inhibitors work by promoting the removal of glucose through the kidneys. This means that a patient’s urine contains a high volume of sugar, which creates a bodily environment very conducive for the growth of bacteria. Though SGLT2 inhibitors such as Invokana®, Farxiga® and Jardiance® have been associated with an abnormally higher incidence of urinary tract infections, the association with Fournier’s Gangrene appears to be a recent revelation to the FDA.

Necrotizing fasciitis of the genitals and genital area, commonly known as Fournier’s Gangrene, is an uncommon bacterial infection that can develop in the scrotum, penis, labia, perineum, essentially any area from the genitals to the rectum. “Necrotizing” means that unchecked, the infection can destroy flesh so treatment of advanced cases usually involves surgery to stop its spread. If left untreated, Fournier’s Gangrene can lead to amputations and death.

According to the Centers for Disease Control (the “CDC”), the first onset of symptoms can be “confusing” since a red or swollen area of the skin is first to appear. However, swelling and fever can develop quickly. The FDA warns that:
“Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.”

New Warning Added to Prescribing Information

In October, 2018, all of the SCLT2 Inhibitors - Invokana®/Invokamet®/Invokamet® XR, Jardiance®/Glyxambi®/Synjardy®/Synjardy® XR, Farxiga®/Xigduo® XR/Qtern®, Stelgato®/Steglatro®/Segluromet®/Steglujan® added the following warning to their Prescribing Information:

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) Reports of necrotizing fasciitis of the perineum (Fournier’s gangrene), a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors. Cases have been reported in both females and males. Serious outcomes have included hospitalization, multiple surgeries, and death. Patients treated with SGLT2 inhibitors presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise, should be assessed for necrotizing fasciitis. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue SGLT2 inhibitor use, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.

Frequently Asked Questions

What should I do if I’m taking Invokana®, Farxiga®, Jardiance® or any other SGLT2 Inhibitor and am concerned about the health risks?

You should not stop taking your medication. You should contact your doctor if you have not already done so. You and your doctor can discuss your concerns and options regarding your medical care and medications.

What are my legal options?

If you had a lower-limb amputation or developed Fournier’s Gangrene while taking Invokana®, Farxiga®, Jardiance® or any other SGLT2 Inhibitor, you may be entitled to compensation for your injury as well as for the expense, mental anguish and inconvenience you incur as a result of any medical and rehabilitation treatment.

What are the legal fees?

There are no legal fees unless you receive compensation in the form of a settlement or award. This is called a contingent fee and is a percentage of your award. We are only entitled to such a fee if we are successful in obtaining an award or settlement for you.

Do I have to advance money for costs?

No, you do not have to advance any moneys for costs. We will advance the money necessary to pay for the out-of-pocket costs required to prosecute your case. If you receive a settlement or award, we will be reimbursed out of the settlement for the costs we advanced on your behalf. If you do not receive a settlement or award, you owe nothing.

How soon will you begin work on my case?

As soon as we receive your signed Retainer Agreement, we will begin work on your case. The initial phase of this work will be to conduct an interview with you, obtain pertinent medical records and evaluate your potential claim. To do so, you also need to sign and return the HIPPA medical releases.