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FDA Strengthens Warnings for Diabetes Medications

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Kaitlynn Martin1 year ago

The U.S. Food and Drug Administration (FDA) strengthened warnings for type 2 diabetes medications canagliflozin and dapagliflozin due to a risk of acute kidney injury.

Details on the Medication Warning

The medications are sodium-glucose cotransporter-2 inhibitors, which are used with diet and exercise to lower blood sugar.

The FDA approved canagliflozin in March 2013, and through October 2015 there were 101 confirmed cases of acute kidney injury.

Among these cases, about half of the patients experienced acute renal injury only within a month of using.  Some of these patients were dehydrated, had low blood pressure, or took other drugs that could possibly affect kidneys as well.

A number of the patients required hospitalization and dialysis.

New data from the EMPA-REG OUTCOME trial showed that it significantly reduces the progression of renal disease in the population of the Type 2 Diabetes patients who were studied, who were also at high cardiovascular risk.

Recommendations for the Medications

For healthcare professionals, the FDA advises the consideration of factors that may predispose their patients to acute kidney injury before starting the medication. Other recommendations include:

  • Assessing the patient’s kidney function, and then continue to monitor their kidney function. 
  • Watch for predisposing factors such as decreased blood volume, chronic renal insufficiency, and congestive heart failure. 
  • Discontinue use if acute kidney injury occurs.

When it comes to patients, they should be aware of the recommendations that come with taking the medications, this includes:

  • Patients who experience signs and symptoms of acute kidney injury should seek medical attention.
  • The warnings instruct patients not to discontinue use of their medications without first consulting their healthcare provider, as uncontrolled blood glucose levels can rise.

Healthcare professionals and patients should report adverse events or side effects related to the use of these medications to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.


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