Invokana – Fournier’s gangrene
Type 2 diabetes is a medical condition affecting over 9% of the population or an estimated 28 million Americans. The most common drug to treat Type 2 diabetes is Invokana.
Manufactured by Johnson & Johnson, Invokana is the brand name of the drug canagliflozin, which is a sodium glucose cotransporter-2 (SGLT2) inhibitor. This class of Type 2 diabetes drugs lowers blood sugar by causing the kidneys to remove sugar from the body via urine.
Before issuing a warning, the FDA said it identified 12 cases of developing the life-threatening bacterial infection, Fournier’s gangrene. The bacteria can infiltrate the tissue under the skin that surrounds the genital area. The bacteria usually enter the body through a cut and quickly spread. Also, having diabetes is a risk factor for developing Fournier’s gangrene. Between March 2013 and May 2018, the agency received 12 cases of the disease (7 found in men and 5 in women). One patient died. However, many others needed multiple disfiguring surgeries that caused severe complications. For all involved, Fournier’s gangrene occurred within mere months of starting Invokana.
Deadly Fournier’s Gangrene
Fournier’s gangrene involves an infection in the scrotum, penis, or perineum in a man. Whereas, the infection in a woman is in the vulva or perineum. It usually gets into the body through a cut or breaks in the skin. The dead or dying tissue in people with this type of gangrene is often found in the genitals and can stretch to the thighs, stomach, and chest. Infection near the genitals causes Fournier’s. The infection occurs in 1.6 out of 100,000 males annually in the U.S. It most frequently occurs in males 50-79 years. Those taking Invokana are at a heightened risk for skin ulcerations that make users susceptible to infections and amputations.
The European Medicines Agency (EMA) and The FDA warned of the risk of infections and ulcerations in 2017. The Canagliflozin Cardiovascular Assessment Study (CANVAS) found that 7 out of 1,000 patients taking Invokana will need lower-limb amputation. This seems like a small number; however, it truly is massive when you consider that Invokana is the best-selling inhibitor drug on the market for Type 2 diabetes. On May 16, 2017, the FDA issued a new Black Box warning for the Type 2 diabetes drug, Invokana, Invokamet and Invokamet XR. Due to new data from the clinical trials CANVAS and CANVAS –R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus), the FDA felt these medications deserved the most severe warning in regards to lower limb amputations.
Currently, there is no warning on Invokana about the risk of Fournier’s gangrene.
Symptoms of Fournier’s Gangrene
- Pain and swelling in the genitals or anal area
- Unpleasant odor coming from the affected skin tissue
- Crackling sound when touching the affected area
When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury as a result of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect other people and their families from needless distress.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. A jury may give compensation for their injuries and damages. The types of losses include:
Also, if a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Therefore, if the conduct of a drug company in manufacturing and selling drug is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed Fournier’s gangrene after taking Invokana, please speak to us to learn more about your rights.
Also, case evaluations are free of cost and without obligation. Call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.