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FDA Strengthens Kidney Warnings on SGLT2 Inhibitor Diabetes Drugs

The U.S. Food & Drug Administration (FDA) has upgraded the existing warning about a risk of acute kidney injury with the type 2 diabetes medications Invokana, Invokamet, Farxiga and 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 a settlement by filing a suit and our lawyers can help.

What’s the Problem?

June 14, 2016 – Based on recent reports, FDA has changed warnings on SGLT2 inhibitor labels to include information about acute kidney injury and added recommendations to minimize the risk of this side effect. Between March 2013 and October 2015, the agency received at least 101 confirmable reports of acute kidney injury — some requiring emergency hospitalization and dialysis treatment — associated with canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga and Xigduo XR). FDA cautions that this number only includes submitted reports, and that there are likely additional cases of which it is unaware.

FDA Recommendation

FDA is advising healthcare professionals to consider factors that may predispose patients to kidney failure, and to assess kidney function before prescribing Invokana, Invokamet, Farxiga or Xigduo XR. Factors that may increase the risk of kidney damage include:

  • Decreased blood volume
  • Chronic kidney insufficiency
  • Congestive heart failure
  • Taking other medications including diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) and nonsteroidal anti-inflammatory drugs (NSAIDs).

Patients should seek immediate medical attention if they experience any symptoms of acute kidney injury such as decreased urine output or swelling in the legs or feet. If you are currently taking a canagliflozin or dapagliflozin-containing medication and are worried about these risks, you should talk to your doctor about possibly switching to a drug with less severe side effects. However, you should never quit taking a prescription medication without talking to your doctor first.

Do I Have an Invokana Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokana lawsuits. We are handling individual litigation nationwide and currently accepting new kidney injury cases in all 50 states.

Free Confidential Case Evaluation: Again, if you were injured by Invokana side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

Free Confidential Case Evaluation

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