FDA Updates SGLT2 Warnings for Invokana and Farxiga

By Rheingold Giuffra Ruffo & Plotkin LLP

On June 14, 2016, the FDA posted on its website, updates of warning labels on two Type 2 diabetes drugs to warn of acute kidney injuries: canagliflozin (Invokana) and dapaliglozin (Farxiga). These two drugs are used in adults with Type 2 diabetes to lower blood sugar levels by causing the kidneys to remove sugar through urine. This call for stronger warning labels was initiated because of 101 reports the FDA has received on confirmable cases of acute kidney injury from March 2013 to October 2015 with cases ranging from mild to severe.

The new warning recommends to healthcare professionals that certain patients are more prone to develop acute kidney injury if they have decreased blood volume, chronic kidney insufficiency, congestive heart failure, or are taking other medications that may interfere and react with the above Invokana/Farxiga. It was also found that these acute kidney injuries were found within one month of starting the drug and the problems discontinued after stopping the drug. However, these new warnings do not apply to other drug in the same class, empagliflozin (Jardiance), because side effects take a longer time to develop. More information can be found on this announcement on the FDA’s main page here.

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