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# FDA Orders Stronger Kidney Warning on Diabetes Drugs
- URL: https://www.fdaweb.com/fda-orders-stronger-kidney-warning-on-diabetes-drugs/
- Published: 2016-06-14T12:00:00.000Z
- Updated: 2026-09-14T21:09:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135936

FDA has strengthened an existing warning about the risk of acute kidney injury for Type 2 diabetes medicines canagliflozin (Janssen’s Invokana and Invokamet) and dapagliflozin (AstraZeneca’s Farxiga and Xigduo XR). “Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk,” an FDA [safety alert ](http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm?ref=fdaweb.com)says.  

From 3/2013, when canagliflozin was approved, to 10/2015, FDA received reports of 101 “confirmable cases” of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use (see [Drug Safety Communication](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwNjE0LjYwMjc3MzIxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDYxNC42MDI3NzMyMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NzQwMTcyJmVtYWlsaWQ9am95Y2VuZS5oYXJyZWxsQGZkYS5oaHMuZ292JnVzZXJpZD1qb3ljZW5lLmhhcnJlbGxAZmRhLmhocy5nb3YmdGFyZ2V0aWQ9JmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&100&&&http://www.fda.gov/Drugs/DrugSafety/ucm505860.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)). “This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware,” the agency says.

The agency recommends that healthcare professionals consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. “These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs),” it says. “Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.”