FDA Safety Warning On Invokana Causes Kidney Injuries

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On June 14 of 2016, FDA has strengthened existing warnings about the risk of acute kidney injury associated with the SGLT2 inhibitors, canagliflozin (brand names Invokana, Invokamet) and dapagliflozin (brand names Farxiga, Xigduo XR). Based on recent reports, The US Food and Drug Administration (FDA) issued a safety alert which revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. Invokana and Invokamet entered the market in 2013 and sold under license by Janssen Pharmaceuticals, a division of Johnson & Johnson. In two short years 1000’s of patients are already starting to experience serious adverse events and other side effects.

The FDA approved Invokana in March 2013, when it 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. For approximately about half of those cases, the patients had been on Invokana for a month or less, and most improved upon discontinuing the drug. Invokana from Johnson & Johnson is used to maintain lower blood glucose levels in patients with type 2 diabetes. The drug belongs to a class of medications called “sodium-glucose co-transporter 2 (SGLT2) inhibitors,” which works by making the kidneys remove sugar from the body through the urine rather than have it be reabsorbed into the blood.

Invokana Kidney Failure

Kidney Failure happens when kidneys stop properly filtering waste and fluid. One may experience swelling, shortness of breath, fatigue, abnormal heart rhythms or even death. Patients on the Type 2 diabetic drug Invokana or similar SGLT-2 inhibitor drugs must learn to recognize the symptoms of kidney failure, which can be fatal if not diagnosed and treated promptly. In its first twelve months on the market, Invokana, manufactured by Johnson & Johnson and its subsidiary, Janssen, was linked to 54 cases of kidney failure and renal impairment. 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. Some of the most common symptoms associated with kidney failure include the following:

  • Pain in the abdomen
  • Shortness of breath
  • Difficulty concentrating
  • Extreme fatigue or lethargy
  • Decreased urine production (only seen in some patients)
  • Diarrhea



Despite the fact that Johnson and Johnson and Janssen were most certainly aware of research which linked these serious health issues with the use of SGLT-2 inhibitor drugs, the manufacturers continued to market the drug and neglected to warn of serious, even deadly risks. It is believed that if more pre-trial testing had been required by the FDA, then many believe Inkokamet and Invokana would not have reached the market shelves. FDA is currently investigating this new safety issue and will update the public when we have more information.

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