Between July 8, 2016 and August 17, 2016, the FDA approved important safety updates to the labels of all SGLT2 inhibitors. These drugs are used to treat Type 2 diabetes by causing the kidneys to remove excess glucose from the body through the urine.

Taken as a whole, the new safety labeling changes warn that there have been fatal cases of ketoacidosis in patients taking any and all of the drugs containing SGLT2 inhibitors. These include Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance, Glyxambi, and Synjardy. Ketoacidosis is a serious metabolism-related condition that occurs when the liver releases too many ketones (acidic molecules). This can result in toxic levels of ketones in the blood requiring hospitalization and can lead to death.

The FDA has already issued two prior warnings and has approved previous safety updates to the labels of all SGLT2 inhibitors alerting about the risk of ketoacidosis and discussing cases requiring hospitalization or emergency room visits. The newest safety labeling changes are the first to report ketoacidosis cases resulting in fatal outcomes.

The FDA has also previously issued warnings and requested label changes related to other serious risks with SGLT2 inhibitors, such as urinary tract infections (urosepsis and pyelonephritis), limb amputations, and acute kidney injury.


If you have suffered from one of these serious conditions after taking Invokana or other SGLT2 inhibitors, our experienced defective pharmaceutical lawyers at Kaiser Gornick LLP can help you explore your options for recovering compensation. We are a leading product liability litigation firm that has successfully recovered hundreds of millions of dollars for clients against big companies and pharmaceutical giants. Start your case on a no recovery, no fee basis.