The U.S. Food & Drug Administration (FDA) has upgraded the current kidney injury warnings on labels of the SGLT2 inhibitor diabetes medications canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).
Free Confidential Lawsuit Evaluation: If you or a loved one was injured, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the Problem?
June 14, 2016 – Since canagliflozin was approved in March 2013 through October 2015, at least 101 confirmable cases of acute kidney injury (canagliflozin=73, dapagliflozin=28) have been associated with the SGLT2 inhibitors, according to an FDA Drug Safety Communication issued today. Hospitalization was required in 96 patients; of these, 22 involved admission to an intensive care unit (ICU) and 4 deaths occurred during hospitalization.
Additionally, 15 patients received dialysis, of which 3 had a pre-existing history of chronic kidney disease (CKD) or previous acute kidney injury; 6 patients reported concomitant use of an ACE inhibitor and a diuretic. In about half the cases, kidney damage occurred within 1 month of initiating treatment with SGLT2 inhibitors; most patients improved upon cessation of the offending medication.
FDA is advising healthcare providers to be mindful of factors that may predispose patients to acute kidney injury before prescribing canagliflozin or dapagliflozin. Risk factors include:
- Decreased blood volume
- Chronic kidney insufficiency
- Congestive heart failure
- Concomitant use of diuretics, ACE inhibitors, ARBs or NSAIDs.
Patients’ kidney function should be assessed before initiating treatment and monitored periodically thereafter. Healthcare providers should consider temporarily discontinuing SGLT2 treatment in any setting of reduced oral intake (eg, acute illness, fasting, fluid losses). If acute kidney injury occurs, the offending medication should be terminated and the injury treated.
Patients who experience any signs of kidney damage should seek immediate medical attention. Signs and symptoms may include decreased urine or swelling in the legs or feet.
Do I Have a Diabetes Drug Kidney Injury Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in SGLT2 inhibitor lawsuits. We are handling individual litigation nationwide and currently accepting new kidney failure cases in all 50 states.
Free Confidential Case Evaluation: Again, if you suffered kidney damage after taking Invokana, Invokamet, Farxiga or Xigduo XR, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.