FDA Confirms Acute Kidney Damage from Invokana, Invokamet and Farxiga

invokana-warning kidney-damageThe 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, the FDA has revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.

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.

Since canagliflozin was approved in March 2013 to October 2015, the 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 agency is  unaware.

The FDA recommends that healthcare 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 and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs).

Acute kidney injury 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.  

Subscribers to Mass Tort Nexis can see original complaints filed in Invokana litigation in state and federal courts..


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