FDA Warns that Invokana Causes Leg and Foot Amputations

Invokana Diabetic-KetoacidosisThe FDA is alerting the public about results of an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet).

It has not determined whether canagliflozin increases the risk of leg and foot amputations. FDA is currently investigating this new safety issue and will update the public when we have more information.

See the FDA Drug Safety Communication for additional details regarding the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial. Mass Tort Nexus has an overview of litigation involving Invokana.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

Defendants that manufactured Invokana are:

  • Janssen Research & Development
  • Johnson and Johnson
  • Janssen Pharmaceuticals,Inc.
  • Janssen Ortho
  • Mitsubishi Tanabe Pharma Corporation

Health care professionals should follow the recommendations in the canagliflozin drug labels. Monitor patients for the signs and symptoms described above and advise patients to seek medical advice if they experience them.

Patients should not stop or change their diabetes medicines without first talking to their health care professional. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.

According to a lawsuit filed in Georgia, defendants’ warning information for Invokana does not address the increased risk of diabetic ketoacidosis or kidney failure, merely stating that a “possible side effect” of Invokana is “kidney problems.”

Due to the defective nature of Invokana, patiends who were prescribed and ingested it, for even a brief period of time, were at increased risk for developing serious, and sometimes life-threatening, complications, including ketoacidosis.

Defendants withheld and concealed their knowledge that Invokana can cause serious, and sometimes life-threatening, complications, including diabetic ketoacidosis from the Plaintiff, other consumers, their physicians, the medical community at large and the general public.

Larry Bodine

Attorney Larry Bodine is Editor of Mass Tort Nexus, and the Editor of The National Trial Lawyers. He is the former Editor in Chief of Lawyers.com and the American Bar Association Journal. He is a cum laude graduate of both Seton Hall University Law School and Amherst College.

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