The FDA released a statement warning that the Type 2 diabetes medication, Invokana could cause a serious genital infection. The agency has received reports of one death already along with 11 other people also needing hospitalization. Currently, there is no labeling to warn consumers of this danger.
Invokana was the first in a new class of drug for Type 2 diabetics. It was supposed to help people easily manage their diabetes without insulin by lowering blood sugar by causing the kidneys to remove sugar from the body via urine. This prevents blood from reabsorbing the sugar. In March 2013, the FDA approved Invokana. However, by May 2015 they were warning that Invokana may lead to devastating side effects. Some of these include ketoacidosis, lower limb amputation, and kidney damage.
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. 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. 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. An infection near the genitals causes Fournier’s. 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.
Help For Invokana Victims
If you developed Fournier’s gangrene or had lower limb amputation, ketoacidosis or kidney damage after taking Invokana, you need an attorney with experience helping people who have been harmed by pharmaceutical drugs. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against drug manufacturers to get clients what they need.
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 complications after taking Invokana, please speak to us to learn more about your rights.
At the present time, The Michael Brady Lynch Firm is concentrating on Pennsylvania. This is the location where our cases are pending against the makers of Invokana. There are over 150 cases there for those injured by Invokana who live all across the country. Just like our other clients, you deserve compensation. It can never replace what you have lost. But, it can help you recover medical expenses, lost wages and the loss of an ability to work. The consultation is completely free, and you are under zero obligation. We are available 24/7 to take your call.