FDA strengthens kidney warnings for diabetes medicines Canagliflozin and Dapagliflozin
The FDA ( Food and Drug Administration ) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines Canagliflozin ( Invokana, Invokamet ) and Dapagliflozin ( Farxiga, Xigduo XR ).
Based on recent reports, FDA has revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body.
Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet.
Health care professionals should 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 ).
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.
Canagliflozin and Dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. They belong to a class of drugs called sodium-glucose cotransporter-2 ( SGLT2 ) inhibitors.
Canagliflozin and Dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
From March 2013, when Canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with Canagliflozin or Dapagliflozin use.
This number includes only reports submitted to FDA, so there are likely additional cases about which FDA is unaware.
In approximately half of the cases, the events of acute kidney injury occurred within 1 month of starting the drug, and most patients improved after stopping it.
Some cases occurred in patients who were younger than 65 years. Some patients were dehydrated, had low blood pressure, or were taking other medicines that can affect the kidneys. ( Xagena )
Source: FDA, 2016
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