FDA and CDC Warn About Flesh-Eating Diseases

Diabetes Drug Infection Lawsuit News

US Government Agencies are concerned that certain types of diabetes drugs can cause Fournier's gangrene

Monday, February 18, 2019 - The Center for Disease Control (CDC) promotes acting fast in order to minimize the devastating effects of necrotizing fasciitis or skin-eating disease. Necrotizing fasciitis is a fast-spreading and potentially lethal disease. Treatment for the disease is limited to debridement, the removal of dead tissue, followed by full-spectrum antibiotics both intravenously and also packed into the open wound. Doctors usually cut away a fair amount of seemingly healthy tissue to ensure that they have removed all of the necrotic tissue, much like forest firefighters back burn to stop the spread of a fire. The CDC warns that necrotizing fasciitis patients experience fever, dizziness, and nausea after having surgery or suffering an injury.

Diabetic patients taking certain SLGT2 blocker medications called sodium-glucose cotransporter-2 (or SGLT2) inhibitors, such as the popular Invokana, have reported developing a certain substrain of necrotizing fasciitis called Fournier's gangrene. Fournier's gangrene usually occurs in males and destroys the tissue of the male genitalia in between the anus an scrotum. The FDA described the outbreak of Fournier's gangrene as a form of "necrotizing fasciitis of the perineum." In addition to the CDC warnings on necrotizing fasciitis, the US Food and Drug Administration (FDA) has expressed concern that an outbreak of Fournier's gangrene may have occurred. As recently as September of 2018, the FDA issued a warning entitled: "FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes."

According to FDA podcast sources, "SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. They lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin." Fournier's gangrene is a bacterial infection that can enter the tissue that lies just below the skin and above the muscle, nerve, fat tissues and blood vessels of the perineum, is extremely rare and affects only about 1 in 50,000 males annually in the US, usually males 50-79, according to the FDA. 12 cases of Fournier's gangrene have been identified in which 7 were male. All developed the disease within 6 months of starting SGLT2 inhibitor drugs and required surgery including radical amputation of the male genitalia.

The FDA has issued a warning that the following diabetes drugs have been linked to Fournier's gangrene, a rare but often deadly genital flesh-eating disease. If you are taking any of the following diabetes medications, please consult your physician immediately. Canagliflozin (Invokana, Invokamet, Invokamet XR), Dapagliflozin (Farxiga, Xigduo XR, Qtern), Empagliflozin (Jardiance, Glyxambi, Synjardy, Synjardy XR), and Ertugliflozin (Steglatro, Segluromet, Steglujan). If you are taking any of the diabetes drugs listed above and experience redness, blisters, skin discoloration or skin ulcers, swelling, and pain in the affected area accompanied by a high fever, nausea, vomiting, and other flu-like symptoms, like fatigue and diarrhea, do not discontinue using the drug but see your physician immediately.

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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.