FDA Strengthens Kidney Warnings for Diabetes Drugs


Drug labels for canagliflozin and dapagliflozin revised to include acute injury warning.

The FDA recently strengthened existing kidney warnings for the type 2 diabetes drugs canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) due to recent concerns.

These sodium-glucose cotransporter-2 inhibitors are used to help lower blood sugar. The drug warning labels were updated to include information about acute kidney injury and ways to reduce this risk, according to a press release from the FDA.

The report found that from March 2013 to October 2015, there were 101 confirmable cases of acute kidney injury from these drugs. Some patients needed hospitalization and even dialysis.

However, these are only the cases reported to the FDA and they believe it is likely there are additional cases.

The FDA states that approximately half of the patients suffered acute kidney injury within 1 month of starting the drug, and a majority of patients improved after stopping treatment.

The FDA urges patients taking these medications to seek medical attention if they start to experience signs and symptoms of acute kidney injury, such as decreased urine or swelling of the legs or feet.

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