Invokana

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    Invokana Criteria

    • Took one or more of the following medications for diabetes
      • Canagliflozin
      • Invokana
      • Invokamet
      • Invokamet XR
      • Sulisent
      • Dapagliflozin
      • Farxiga
      • Xigduo XR
      • Empagliflozin
      • Jardiance
      • Glyxambi
      • Synjardy
      • Tofogliflozin
      • Apleway
      • Deberza
      • Steglatro
      • Stegluromet
      • Qtern
    • Suffered from any of the following injuries while on the medication
      • Genital infection
      • Necrotizing fasciitis
      • Fournier's gangrene
      • Gangrene
      • Ischemia
      • Necrosis
      • Diabetic foot syndrome
      • Recurring infections
      • Charcot foot
      • Chronic ulcers or sores
      • Amputation
      • Kidney failure
      • Chronic kidney disease
      • Ketoacidosis
      • Diabetic coma
    • No legal representation

    Invokana Background Information

    Products

    Invokana, Invokamet, Farxiga, Glyxambi, Jardiance, Xigduo XR

    MDL 2750 (Invokana)

    District of New Jersey, U.S. District Judge Brian R. Martinotti

    MDL 2776 (Farxiga)

    Southern District of New York, U.S. District Judge Lorna G. Schofield

    Manufacturers

    Johnson & Johnson, Janssen Pharmaceuticals Inc., AstraZeneca, Boehringer Ingelheim

    Issues/ injuries

    Failed to warn patients and physicians of the increased risks of kidney failure, heart attacks, ketoacidosis and diabetic ketoacidosis (DKA), loss of bone density, and severe Urinary Tract Infections (UTIs) requiring hospitalization.

    Timeline of Events

    • 5/15/15 – FDA puts out a safety announcement that SGLT2 inhibitors may lead to ketoacidosis.
    • 5/18/17 – FDA issues new Black Box warning in regards to increased risk of leg, foot, and toe amputations for Invokana, Invokamet, and Invkoamet XR
    • 6/08/17 – JAMA new study published in the New England Journal of Medicine shows that SGLT2 inhibitors appear to have double the risk for DKA when compared to DPP-4 inhibitors
    • 8/29/18 – FDA issues a black box warning that SGLT2 inhibitors have been linked to Fourier’s gangrene, a rare, serious “flesh-eating” infection around the genitals

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