Invokana Diabetes drug linked to flesh-eating genital infections. According to the latest FDA warnings Invokana, Jardiance, Farxiga and similar newer diabetes drugs increase the risk of serious genital infections.
The FDA issued a warning recently, noting that the drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors increase the risk of serious genital infections.
The genital infections involve necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, and “flesh-eating” infection.
According to the FDA, “In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor. This number includes only reports submitted to FDA and found in the medical literature, so there may be additional cases about which we are unaware.”
Diabetics Susceptible to Fournier’s Gangrene
Necrotizing fasciitis of the perineum or Fournier’s gangrene is a serious and potentially deadly infectious condition causing the death of tissue, muscle, nerves and blood vessels in the perineum. The perineum is the area between the area between the anus and the scrotum or vulva. Left untreated gangrene can spread from the genitals to the legs, stomach, and chest.
New FDA Infection Warning Labels
The FDA is requiring new label infection warnings be added to all drugs that belong to the class, including Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet, and Steglujan.
The FDA notes that the infections developed within several months of beginning treatment with one of the drugs and all 12 patients underwent hospitalization and surgery. At least one patient died, while others suffered disfiguring surgeries and other serious complications.
Invokana also linked to increased Amputation side effects
Johnson & Johnson and it’s Janssen subsidiary are under intense scrutiny over claims that the companies failed to adequately research the potential side effects of Invokana.
Diabetic folks are alarmed over the increased risk of serious and in some cases catastrophic side effects of Invokana. Invokana has been linked to an increased risk of diabetic ketoacidosis, kidney failure, and leg amputations.
What is Invokana?
Invokana (canagliflozin) was approved for sale in March 2013, as the first member of a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. These are type 2 diabetes medications that help to control blood sugar by stimulating the kidneys to remove glucose (sugar) from the body through the urine.
Similar SGLT2 drugs include Invokamet, Jardiance, Farxiga, Xigduo, and Invokana has the largest market share.
Invokana Injury lawsuits over 1,000
The Invokana side effect injury cases are concentrated in the U.S. District Court for the District of New Jersey, and more than 1,000 have been filed for centralization and coordination for pretrial proceedings, as part of federal multidistrict litigation (MDL).
The Invokana side effect cases involve three different injury categories, kidney failure, diabetic ketoacidosis, and allegations that Invokana increases the risk of amputations.
FDA Warnings over Invokana Side Effects
Since Invokana’s release, there have been many reports of catastrophic health complications from patients taking the type 2 diabetic medication. The FDA has ordered many warning label updates over the past several years.
In December 2015, the FDA ordered Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, finding that the drug increases the risk of this dangerous medical condition.
In June 2016, the FDA ordered new label warnings about Invokana and kidney risks, finding that the drug increases the risk of acute kidney failure.
In May 2017, the FDA ordered new label warnings about Invokana and the increased risk of leg and foot amputations.
If you or someone you know developed Invokana Ketoacidosis, leg, foot, toes amputations or kidney failure by taking Invokana for the treatment of their type 2 diabetes, please call us for further information at 888-210-9693. Dr. Shezad Malik Law Firm based in Dallas, Texas is investigating Invokana Wrongful death, Invokana Ketoacidosis, leg amputations, and kidney failure cases nationwide from folks taking Invokana for the treatment of their type 2 diabetes.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.