Robins Kaplan LLP Investigates Type 2 Diabetes Drugs and Severe Injuries, Including Ketoacidosis

In May 2015 the FDA issued Safety Communication, advising that certain Type 2 Diabetes drugs result in a serious condition known as ketoacidosis.¹   The FDA reported that it had received reports of 20 cases of ketoacidosis, all of whom required trips to the ER or hospitalizations to treat the ketoacidosis.²   The FDA is continuing to investigate this issue.³

The Drugs:

The FDA’s Safety Communication was limited to the class of Type 2 Diabetes drugs known as “sodium-glucose cotransporter-2” or “SGLT2” inhibitors.⁴   These drugs include:

1)       Invokana and Invokamet (canagliflozin and canagliflozin plus metformin);
2)       Farxiga and Xigduo XR (dapagliflozin and dapagliflozin plus metformin extended release); and
3)       Jardiance and Glyxambi (empagliflozin and empagliflozin plus linagliptin).⁵

The drugs are approved for use to treat Type 2 diabetes; they have not been approved to treat Type 1 diabetes.⁶   These drugs cause the kidneys to remove sugar from the body by excreting it through urine, thus lowering blood sugar.

The Injuries:

The FDA’s Safety Communication identified ketoacidosis is a possible condition related to the use of SGLT2 inhibitors.⁷   Ketoacidosis occurs when the body uses fat, rather than glucose, to fuel itself.⁸   When fat is metabolized, ketones are released into the body.⁹   Ketones are acids, which in high levels, can be toxic to the body and result in ketoacidosis.¹⁰ Symptoms of ketoacidosis are: excessive thirst, frequent urination, nausea and vomiting, abdominal pain, weakness or fatigue, shortness of breath, fruity-scented breath, and confusion.¹¹   Treatment usually consists of intravenous fluid replacement, intravenous electrolyte replacement and/or intravenous insulin therapy.¹²   Untreated, ketoacidosis can result in death.¹³

We are also investigating a possible association between the SGLT2 inhibitors and kidney failure, and cardiac events.  For a free case evaluation, please call 1.800.553.9910 (toll-free) or contact us online. Our medical advisors are standing by.