FDA Strengthens Warnings About Canagliflozin and Dapagliflozin

The FDA strengthened its existing warnings about the risk of acute kidney injury while taking canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

The FDA decided to revise the warnings on the type 2 diabetes drug labels to include info about the potential kidney problems, and it also added recommendations to minimize the risks.

Between 2013 (when cangliflozin was approved) and 2015, the FDA saw 101 cases of acute kidney injury associated with the use of canagliflozin or dapagliflozin.

“This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware,” the FDA wrote in a statement.

The FDA recommended that health care providers consider factors that might make patients more likely to experience acute kidney injury prior to starting them on these medications. Some risk factors include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs.

If patients experience signs or symptoms of acute kidney injury (decreased urine, swelling in the legs or feet), they should seek medical help immediately.

However, patients should not stop taking their medication without talking to their health care professional, since doing so could lead to uncontrolled blood sugar levels.

Patients’ kidney function should be assessed prior to taking these medications, and it should be monitored periodically while on the therapies.