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CASE UPDATE: Life-threatening, Flesh-eating Bacteria Can Result From Invokana, SGLT-2 Inhibitor Use
February 2019 - Recently, we learned of a new injury that can be related to Invokana use. Genital gangrene, sometimes known as Fournier's gangrene or necrotizing fasciitis of the genital region, can be caused by SGLT-2 inhibitors like Invokana, Farxiga, and Jardiance. This condition is rare, but if you have experienced it while using one of these drugs, please immediately seek medical treatment. After, contact TorHoerman Law.
Invokana, approved by the U.S. Food and Drug Administration (FDA) in 2013, is part of a class of Type 2 diabetes drugs called sodium-glucose cotransporter-2 (SGLT-2) inhibitors. SGLT-2 is a protein in humans that facilitates glucose reabsorption in the kidneys, and SGLT-2 inhibitors block the reabsorption of glucose in the kidneys, increase glucose excretion, and in turn lower blood glucose levels. SGLT-2 inhibitors are commonly used to treat adults with Type 2 diabetes.
Studies and trials have shown Invokana, and similar SGLT-2 drugs such as Jardiance and Farxiga, to be highly effective in controlling blood glucose levels and lowering hemoglobin levels for patients with Type 2 diabetes.
Because of its effectiveness, the popularity of Invokana has increasingly grown since its market introduction. Invokana is considered the most popular drug in its class.
However, Invokana and similar medications have been linked to a number of dangerous and potentially life-threatening adverse health effects.
Invokana was the first drug of its class, approved for market in 2013. Invokana is manufactured by Johnson & Johnson subsidiary, Janssen Pharmaceuticals. Invokamet was approved in 2014. Invokamet XR was approved in 2016.
Invokana has come under fire recently because of the increased risk of lower limb amputations caused by one of its key ingredients, canagliflozin. Physicians in California are hurrying to switch patients from Invokana to other diabetes medications.
The findings 0f a CANVAS trial caused the Food & Drug Administration (FDA) to issue an Invokana black box warning on May 16, warning of the increased risk of amputations; a black box warning is the strongest warning the FDA can issue. Since the warning was issued, doctors began switching patients to other medications because of the Invokana risks, even going as far as calling patients ahead of their scheduled appointments to discuss Invokana risks.
Michael Carome, Director of Public Citizen’s Health Research Group, voiced concern that Invokana risks, specifically the risk of amputation, “….is a significant safety finding and for us, adds to our position that the drug should be avoided.”
SGLT2 inhibitors, such as Invokana, empagliflozin (Jardiance) and dapagliflozin (Farxiga), have also seen additional warnings due to the increased risk of ketoacidosis.
Since Invokana’s approval, a number of studies suggest the medication may increase the risk of dangerous side effects such as kidney damage, diabetic ketoacidosis, risk of lower limb amputations, and now a life-threatening genital infection.
If you are taking Invokana or another SGLT2 inhibitor, it is important to talk with your doctor about the risks associated with the medication.
The first clinical trial, CANVAS (Canagliflozin Cardiovascular Assessment Study), tested the effects on adult patients suffering from type 1 diabetes. The study was conducted over a period of one year with two separate groups: patients given canagliflozin and patients given a placebo.
The risk of amputation for the placebo group was 2.8 of every 1,000 participants, while the risk for the canagliflozin group was 5.9 of every 1,000 participants.
A similar clinical trial, CANVAS-R (Study of the Effects of Canagliflozin on Renal Endpoints) tested adult patients suffering from type 2 diabetes. Again, the study was conducted over a period of one year with two separate groups: patients given canagliflozin and patients given a placebo.
The risk of amputation for the placebo group was 4.2 of every 1,000 participants, while the risk for the canagliflozin group was 7.5 of every 1,000 participants.
In both studies, amputations were most common in patients’ toes and feet, with a smaller percentage needing a full-leg amputation. Some patients required multiple amputations, “some involving both limbs.” Results of the CANVAS trial indicated patients using Invokana were at an increased risk of amputations.
Patients using Invokana who have undergone a previous amputation are at a higher risk of needing another. The FDA urges patients using Invokana, or similar products, to contact their healthcare provider if they notice new pain, sores or ulcers, or infections in their legs or feet. Health care providers should discontinue prescribing the drug if any of these symptoms should occur.
Despite its notable ability to control blood sugar levels, Invokana has some potentially serious side effects:
Starting in 2015, the FDA began to release multiple public safety announcements, warning the public of the links between Invokana/SGLT-2’s and these dangerous adverse effects.
The FDA released a public safety alert, warning type 2 diabetes patients taking SGLT-2 inhibitors that they may be at risk of developing necrotizing fasciitis of the genitals and genital area.
Necrotizing fasciitis of the genital area, also called Fournier’s gangrene, is a life-threatening flesh-eating bacterial infection of the skin surrounding the muscles, nerves, fat, and blood vessels in the genitalia. It is most common among men ages 50 to 79 and occurs in about 1.6 of 100,000 men annually in the U.S. It is very uncommon in women.
The FDA has mandated new prescribing information and patient medication guides making SGLT-2 patients aware of the increased risk of developing Necrotizing fasciitis for the following medications:
Since March 2013, the FDA has received 12 reports of type 2 diabetes patients prescribed SGLT-2 inhibitors who have developed necrotizing fasciitis of the genitalia – five women and seven men ranging from 38 to 78 years old. All of the four SGLT-2 drug-types except ertugliflozin were included in the reports – although there have been no reports so far, the FDA stated that ertugliflozin would be expected to run an equal risk to patients.
For these individuals, the window of development ranged from 7 days to 25 months after taking SGLT-2 inhibitors with an average of 9.2 months.
All 12 individuals who reported developing necrotizing fasciitis of the genitalia were hospitalized and underwent a surgical procedure to remove the infection.
Five of the individuals underwent more than one surgical procedure. One individual required skin grafting. Four of the individuals dealt with post-surgical complications including diabetic ketoacidosis, acute kidney injury, and septic shock. There was one reported death. Two individuals were transferred to a rehabilitation hospital.
Symptoms of Fournier’s gangrene include tenderness, redness, swelling of the genital area, or running a temperature of 100.4 degrees Fahrenheit or higher.
If you are prescribed an SGLT-2 inhibitor to treat type 2 diabetes, and you show any signs or symptoms of Fournier’s gangrene, seek medical attention right away.
Fournier’s gangrene is a degenerating disease, worsening over time. If caught in its early stages, Fournier’s gangrene can be treated with antibiotics; but if left untreated, a surgical procedure may be necessary.
If you are taking an SGLT-2 inhibitor to treat type 2 diabetes, talk to your doctor about the risks of your medication and whether you are eligible for other type 2 diabetic treatments.
If you are currently or were ever taking an SGLT-2 inhibitor, and as a result developed necrotizing fasciitis of the genital area /Fournier’s gangrene, contact the offices of TorHoerman Law. You may be eligible to participate in a type 2 diabetes medication genital infection lawsuit.
At this time, TorHoerman Law is collecting information for a potential type 2 diabetes medication genital infection lawsuit.
Following the release of Invokana, the FDA approved drugs in the same SGLT-2 class. All though they carry a different brand name, these follow-up drugs carry the same risks and warnings as Invokana and Invokamet. These follow-up SGLT-2 inhibitors also include:
Farxiga was first approved for the market in 2014, after being rejected for approval by the FDA in multiple prior pre-market trial phases.
Farxiga is similar to most other SGLT2 inhibitors, with the distinction of being five times more likely to cause bladder cancer. Farxiga may also increase the progression of bladder cancers in patients who are prone to bladder cancer, according to studies conducted by the Cancer Prevention & Treatment Fund
A conglomeration of patients has filed an Invokana lawsuit against the manufacturer, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
The Invokana lawsuit claims Invokana/Janssen:
Hundreds of cases have been filed across the United States, including Pennsylvania, New Jersey, and California, against the manufacturer of Invokana. Cases have been filed in Canada, as well. The bellwether trials are expected to begin in September of 2018.
If you or a loved one was taking Invokana (or a similar SGLT-2) to treat Type 2 diabetes and suffered injuries from the drug, you may be entitled to compensation for your damages with a Type 2 diabetes lawsuit.
Do you have questions about the Invokana lawsuit? Contact TorHoerman Law.
August 2018 -TorHoerman Law is currently evaluating cases for individuals who underwent toe, foot, or leg amputations while on Invokana.
June 8, 2017 - A new study published in the New England Journal of Medicine showed that SGLT-2 inhibitors doubled the risk for diabetic ketoacidosis when compared to DPP-4 inhibitors.
July 6, 2017 - The FDA recently mandated an updated Invokana black box warning, warning consumers of the higher risks associated with these products.
These new warning labels come just one year after the FDA released a warning for increased risk of acute kidney injury for canagliflozin users, as well as a warning of increased risk of bone fracture associated with canagliflozin.
The newest FDA warning label requirement resulted from the findings in two separate Johnson & Johnson in-house clinical trials, both of which revealed increased risks of leg and foot amputation for patients using canagliflozin products. Both trials showed that the likelihood of amputation increased as much as two times for patients prescribed a canagliflozin.
June 2016 - The FDA introduced a new warning for Invokana, Invokamet, Farxiga, and Xigduo XR, linking the SGLT-2 inhibitors to reports of acute kidney injury that required hospitalization in some cases.
May 2016 - The FDA issued a consumer safety alert for SLGT-2 inhibitors.
September 2015 - The FDA revised the Invokana and Invokamet labels to include information about the risk of bone fracture.
May 2015 - The FDA issued a drug safety communication stating that Invokana, Farxiga, and Jardiance may lead to ketoacidosis, and highlighted 20 cases of acidosis in patients treated with SGLT-2 inhibitors from March 2013 to June 2014.
Center for Drug Evaluation and Research. "Drug Safety and Availability - FDA Drug Safety Communication: FDA Revises Labels of SGLT2 Inhibitors for Diabetes to Include Warnings about Too Much Acid in the Blood and Serious Urinary Tract Infections." U.S. Food and Drug Administration Home Page, Center for Drug Evaluation and Research, www.fda.gov/Drugs/DrugSafety/ucm475463.htm.
Monaco, Kristen. "ADA: Canagliflozin Cuts Heart Risk in T2D." Medpage Today, MedpageToday, 12 June 2017, www.medpagetoday.com/mastery-of-medicine/mastery-in-diabetes-management/65973.
Villanueva, Laurie. "Invokana Invokamet Amputation Risk Prompts Some Doctors to Switch." RX Injury Help, 31 Aug. 2017, www.rxinjuryhelp.com/news/2017/08/31/some-california-healthcare-providers-scrap-invokana-invokamet-following-fda-amputation-warning/.
Last Modified: May 5th, 2019 @ 02:53 pm
Patients who have previously been prescribed Invokana -- or similar SGLT-2 inhibitor -- and been injured by the drug may be eligible to participate in an Invokana lawsuit.
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