Pharmaceutical Litigation Attorney’s | Information on Fournier’s Gangrene
In August of 2018, the FDA released a Drug Safety report concerning the use of SGLT2 inhibitors for diabetes such as Invokana, Farxiga, and Jardiance. These types of drugs most commonly referred to as gliflozins block the absorption of sugar into the blood causing the patient to instead flush it out in urine. The FDA warned of rare occurrences of a serious infection in the genital area referred to as Fournier’s gangrene which is a severe flesh-eating bacterial infection of tissue under the skin near the perineum.
Greg Jones Law is currently taking cases against the makers of unsafe diabetes drugs. If you or a loved one has experienced a life changing side effect of Fournier’s Gangrene, Contact us today for a free case evaluation on your lawsuit.
“FDA is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene.”
According to the CANVAS study, out of 1,000 patients studied 5.9 of them had the higher risk of amputation as a result of taking Invokana. This stood in contrast to the 1,000 patients taking a placebo. Only 2.8 of patients taking the placebo had a high a risk of amputation.
A second study called the CANVAS-R, a study of the effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus, was also conducted and confirmed the higher risk of amputation due to Invokana with its results as well. As a result the FDA has required the diabetes drug to carry it’s most severe label, known as the black box label, or Boxed Warning.
Additionally, the FDA states that users should, “seek medical attention immediately if they 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.”
It is most common for the disease to affect males in the age demographic of 50-80 years old but has been found recently to affect both men and women soon after taking Invokana, Farxiga or Jardiance. To compare, in the prior 30 years there were only 6 cases of Fournier’s gangrene identified in reviews of other antidiabetics drug classes. The treatment of Fournier’s gangrene usually involves strong antibiotics or even surgical removal of the tissue. Commonly, patients require multiple surgeries and are potentially at risk of losing their genital organs.
Lawsuits against Johnson & Johnson who is the manufacturer of Invokana contain allegations that the company was negligent in properly testing the drug, that they hid the dangers from the FDA , and that they failed to sufficiently warn patients of the very serious and dangerous side effects such as Fournier’s gangrene. Most of the claims apply to patients that suffered from the serious side effects or were hospitalized due to the use of Invokana.
If you have developed life altering side effects after taking the diabetes drug Invokana an Invokana lawsuit may be an option for you. Greg Jones Law has helped clients force Pharmaceutical companies to take responsibility for the unsafe drugs they marketed and distributed. Many times, plaintiffs in diabetes drug lawsuits would have chosen an alternative drug if they have known of all the potential side effects.
To find out if you have a case against the makers of the medications Invokana, contact us today for a free case evaluation. Call 855-566-3752 or contact us online.
What is Invokana? Information on Invokana warnings & a diabetes drug lawsuit:
Everything you need to know about Invokana side effects.
Learn more about the CANVA study that exposed amputations as a side effect of Invokana.
Our pharmaceutical attorney gives advice on an Invokana amputation lawsuit.
The details behind why people choose an Onglyza lawsuit.