The Food and Drug Administration strengthened an existing warning of the risk of acute kidney injury from the diabetes medicines canagliflozin and dipaglifozin.
The agency revised their warnings on the drug labels, now providing information about acute kidney injury and recommendations to minimize risk of the condition.
Here are four things to know about the warning:
- Canagliflozin and dapagliflozin are prescription medicines paired with diet and exercise to help lower blood sugar in adults with Type 2 diabetes.
- Acute kidney injury is a serious condition where the kidneys suddenly stop working, causing dangerous levels of waste to build up in the body.
- From March 2013 — when canagliflozin was approved — to October 2015, the FDA received reports of 101 confirmable cases of acute kidney injury associated with canagliflozin or dapagliflozin use. This number only represents cases reported to the FDA, so it is likely more cases occurred that were not documented.
- In about half of the cases, acute kidney injury occurred within one month of starting the drug and most patients' conditions improved after stopping it.
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