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June 14, 2016: FDA Strengthens Invokana Kidney Injury Label Warning

Invokana Kidney Injury

Based on recent reports of acute kidney injury associated with the type 2 diabetes medicines Invokana and Invokamet (canagliflozin), and Farxiga and Xigduo XR (dapagliflozin), The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about this risk.

FDA’s Type 2 Diabetes Info

Invokana, Invokmet, Farxiga, and Xigduo XR are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

Invokana, Invokmet, Farxiga, and Xigduo XR lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.


Attorney Eric Weinberg has represented thousands of patients injured by drug adverse events including for example, the products Vioxx, Baycol, Pradaxa, Ortho Evra, and blood clotting products. If you or a loved one has suffered an injury after taking Invokana, Invokamet, or another SGLT2 inhibitor, please contact our firm for a free drug lawsuit evaluation by calling us toll free at 1-877-934-6274. You can also contact a Weinberg Firm lawyer by submitting our easy-to-use free legal case evaluation form.

Invokana Kidney Injury Risk

From March 2013 to October 2015, 101 cases of acute kidney injury, had been reported to the FDA from patients using either Invokana, Invokmet, Farxiga, or Xigduo XR. The FDA Safety Communication noted, “This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware.” Some of these 101 acute kidney injury cases required hospitalization and dialysis.

History of Invokana Injuries

  • On May 19, 2016, the U.S. Food and Drug Administration issued a Safety Announcement informing the public of a study of the diabetes drug Invokana, the results of which suggest an association between the drug and an increased risk of leg and foot amputations.
  • On November 5, 2015, Dr. Sidney Wolfe, founder of and senior advisor to the watchdog group Public Citizen, spoke in front of the U.S. Food and Drug Administration’s (FDA) Advisory Committee, to testify to the large body of evidence showing the relation between these antibiotics and heart rhythm problems.
  • In a Drug Safety Communication dated September 10, 2015, The U.S. Food and Drug Administration (FDA) announced that the warning for the type 2 diabetes drug canagliflozin (Invokana and Invokamet) has been strengthened related to the increased risk of bone fractures.
  • In a Drug Safety Communication dated May 15, 2015, the U.S. Food and Drug Administration (FDA) warned that the type 2 diabetes medications canagliflozin (marketed as Invokana), dapagliflozin (marketed as Farxiga), and empagliflozin (marketed as Jardiance) may lead to a serious medical condition known as ketoacidosis.
  • On August 15, 2013, The U.S. Food and Drug Administration (FDA) asked drug companies to change labeling in order to address the risk of peripheral neuropathy, a type of nerve damage associated with the use of fluoroquinolone antibiotics like Levaquin.
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