The Food and Drug Administration (FDA) has updated warnings on four diabetes medications to minimize the risk of acute kidney injury. Used to treat type II diabetes, canagliflozin and dapagliflozin are sodium-glucose cotransporter-2 (SGLT2) inhibitors that work with the kidneys to maintain safe blood sugar levels.
The warning comes after the FDA reviewed and confirmed 101 cases of acute kidney injury linked to SGLT2 inhibitors. People taking SGLT2 inhibitors were found to have low blood pressure and dehydration. Many of the injuries, reported between March 2013 and October 2015, required hospitalization and dialysis.
Acute Kidney Injury
Acute kidney injury, caused by a buildup of unfiltered waste, occurs when the kidneys stop functioning. Certain symptoms should encourage patients to seek medical attention immediately, including:
- Decreased urine
- Swelling in the legs or feet
- Eating or drinking less due to illness or fasting
- Losing fluids due to vomiting, diarrhea, or excessive heat exposure
Risk Factors
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
- Use of diuretics
- Use of angiotensin-converting enzyme inhibitors
- Use of angiotensin receptor blockers
- Use of nonsteroidal anti-inflammatory drugs
"This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware," the FDA wrote in the safety communication. "In approximately half of the cases, the events of acute kidney injury occurred within one month of starting the drug, and most patients improved after stopping it."
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Generic Name |
Brand Name |
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Canagliflozin |
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Dapagliflozin |
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