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

July 7, 2015

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.

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