FDA strengthens kidney warnings for diabetes medicines Invokana, Invokamet, Farxiga and Xigduo XR

invokana-warning kidney-damageThe U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, it has revised the warnings in the drug labels for these SGLT2 Inhibitors to include information about acute kidney injury and added recommendations to minimize this risk.

Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful.

Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include:

  • Decreased blood volume
  • Chronic kidney insufficiency
  • Congestive heart failure
  • Taking other medications such as:
    • diuretics
    • blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors
    • angiotensin receptor blockers (ARBs)

Canagliflozin and dapagliflozin 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. Canagliflozin and dapagliflozin 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.

101 cases of acute kidney injury

From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use. This number includes only reports submitted to FDA, so there are likely additional cases about which the FDA is unaware. In approximately half of the cases, the events of acute kidney injury occurred within 1 month of starting the drug, and most patients improved after stopping it. Some cases occurred in patients who were younger than 65 years. Some patients were dehydrated, had low blood pressure, or were taking other medicines that can affect the kidneys.

The leading case is Arthur Portnoff V. Janssen Pharmaceuticals, Inc., Janssen Research and Development, LLC, Johnson & Johnson Co., and Mitsubishi Tanabe Pharma Corp., Case ID: 151200653, filed In the Philadelphia Court of Common Pleas.

Portnoff, of Beaumont, Texas, has taken the prescription drug Invokana, which is a member of the gliflozin class of pharmaceuticals, also known as sodium glucose co-transporter 2 (“SGLT2”) inhibitors. SGLT2 inhibitors inhibit renal glucose reabsorption through the SGLT2 receptor in the proximal renal tubules, causing glucose to be excreted through the urinary tract. This puts additional stress on the kidneys in patients already at risk for kidney disease.

While taking Invokana in Philadelphia, Pennsylvania, Portnoff developed diabetic ketoacidosis on or about February 20, 2015, as a result of treatment with Invokana, and was hospitalized at Hahnemann University Hospital in Philadelphia. As a result of his development of diabetic ketoacidosis, he  developed serious complications which required multiple days of hospitalization. Portnoff has endured pain and suffering, emotional distress, loss of enjoyment of life, and economic loss, including significant expenses for medical care and treatment which will continue in the future.

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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