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The U.S. Food and Drug Administration (The FDA) issued a Black Box Warning regarding Invokana® in May of 2017. This warning was sent to physicians and the medical community to address two recently published, independent studies indicating that patients prescribed the Type 2 Diabetes drug, Invokana® (also Invokamet® and Invokamet XR®) had two times the likelihood of needing toe, foot or leg amputation as compared to patients who took a placebo drug.

The results of these studies (named CANVAS and CANVAS-R) were discussed at the 2017 American Diabetes Association conference. While on the positive side, these Invokana® users were 14% LESS likely to experience a cardiovascular event, the risk of amputation doubled. Additionally, in one of the studies, users experienced a higher rate of bone fractures. As a result, patients taking Invokana® should contact their doctors if they develop pain or tenderness, sores or ulcers or infections in their legs or feet. Patients should not discontinue their medications until speaking with a doctor.

This warning follows a previous 2015 FDA warning on Invokana® that came after the FDA’s database identified 20 cases of ketoacidosis and kidney damage requiring hospitalization in the first 14 months of Invokana® being introduced. Additionally, there were over 450 adverse events reported for Invokana® in its first year on the market. The serious side effects linked to Invokana® include:

  • Kidney failure
  • Kidney stones
  • Kidney damage
  • Diabetic foot/leg ulcers (possibly requiring amputation)
  • Urinary tract infections
  • Fluid/electrolyte problems
  • Weight loss
  • Hypersensitivity

Patients who have developed ketoacidosis since beginning Type 2 Diabetes treatment with Invokana® may want to explore their legal options. Currently there are about 500 cases filed in a multidistrict litigation (MDL) against Johnson & Johnson, the maker of Invokana®, alleging that the pharmaceutical company did not adequately warn users of the risks of ketoacidosis. An attorney can help you to determine if your case warrants investigation. Please contact Brett H. Oppenheimer, a Kentucky lawyer, who can help you determine if your case warrants investigation. Email Brett using the form found on this website (or or call (502)242-8877 for a free consultation.

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