New Warning For SGLT2 Diabetes Drugs Include Fournier's Gangrene

Diabetes Drug Infection Lawsuit News

Diabetic patients that have scheduled surgery should temporarily suspend taking sodium-glucose blocker drugs as per their doctor's direction

Thursday, March 19, 2020 - The US Food and Drug Administration (FDA) has approved requiring pharmaceutical companies that manufacture and sell a certain type of diabetes drug to enhance warning labels to inform patients of their dangerous side effects. The FDA is requesting the label update to reflect that diabetics should discontinue taking sodium-glucose transport drugs for type 2 diabetes (SGLT-2), three or four days before scheduled surgery to decrease the risk of infection or other related diseases. SGLT-2 diabetes drug patients report an acid build-up in the blood called Ketoacidosis which can cause a host of medical difficulties, and was at the center of the FDA's decision to approve the warning label enhancement. "The FDA says that it approved the label change because surgery may put patients at greater risk for developing ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness and trouble with breathing."

Diabetic patients will often choose to take sodium-glucose blocker drugs rather than painfully inject themselves with insulin regularly and the drugs work to route sugar out of the blood through the urine. SGLT2 drugs, however, also carry side effects which include a rare type of flesh-eating disease. Common side effects of SGLT2 sodium-glucose blocker drugs include urinary tract infections, low blood pressure, kidney failure, and Fournier's Gangrene, a particularly hideous condition that causes necrotizing fasciitis of the genitals region from the anus to the scrotum. The only treatment for Fournier's Gangrene is amputation of healthy tissue in all directions from the dead tissue to attempt to stay ahead of the rapidly-spreading flesh-eating condition, then packing the surgical wound with antibiotics. According to European Pharmaceutical news, "Canagliflozin is associated with an increased risk of lower limb amputation, while impairment in renal function is also a side effect of empagliflozin and ertugliflozin."

On August 29, 2018, The FDA first warned drug makers to update their SGLT2 drug labels to include the increased risk of users developing Fournier's Gangrene."... 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," The FDA reported. Fournier's Gangrene patients report early warning signs of the disease as swelling, redness, and tenderness of the genitals or perineal area accompanied by fever, malaise, and flu-like symptoms. lists the most potent SGLT2 with the potential to cause adverse side effects as Steglatro (Pro)(ertugliflozin), Invokana (canagliflozin), Jardiance (empagliflozin), and Farxiga (dapagliflozin). Getting to a hospital emergency room as soon as any of the above symptoms present themselves is essential in combating Fournier's Gangrene as the disease spreads rapidly and in can engulf far up into the intestines and stomach in just a few short days. Elderly, poorly-cared-for diabetic nursing home patients are at particular risk of developing the disease. Diabetes drug infection lawsuits attorneys offer a free consultation for those that think they may have a claim.

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Lawyers for Fournier's Gangrene

OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.