Farxiga (dapagliflozin) is one of several drugs in a class known as SGLT2 inhibitors that has been linked with ketoacidosis. This association between this class of drugs prompted an FDA warning in May 2015.

SGLT2 inhibitor drugs are known as sodium-glucose co-transporter 2 inhibitors, and they were formulated in order to the lower blood sugar levels in diabetic patients. When these drugs were initially released, physicians and patients found that some patients who had not responded to diet and exercise as well as other oral diabetic therapies were responding well to Farxiga and related medications.

However, Farxiga ketoacidosis was an unintended and unanticipated side effect that many patients and their physicians were not prepared for.

Farxiga Ketoacidosis: Method of Action

As an SGLT-2 inhibitor, drugs like Farxiga reduce the glucose levels in blood plasma by causing more glucose to be excreted in the urine of patients who take the medication. The reabsorption of glucose into the kidneys is blocked by the drug’s mechanisms, so that excess glucose can be eliminated through the kidneys.

This same mechanism is thought to be the reason why some patients are dealing with abnormally high levels of acid in the blood, produced by ketones, a condition referred to as diabetic ketoacidosis. Ketoacidosis can cause great damage and even death if it is left untreated for too long.

According to the FDA, the adverse event reports affecting users of Farxiga and other SGLT-2 inhibitors stated that Farxiga ketoacidosis and ketoacidosis linked to other SGLT-2 inhibitors was reported by 20 cases, and all 20 individuals were required to be hospitalized. The FDA indicated that the median time between onset of ketoacidosis after having started Farxiga or other drugs was two weeks.

The FDA warning states: “Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experienced symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion and unusual fatigue or sleepiness.” Patients are advised not to stop the drug without consulting with their physician first, but should stop the medication once acidosis is confirmed.

Farxiga is approved to treat type-2 diabetes, which usually has an adult onset in contrast to type-1 diabetes. However, ketoacidosis is rare in type-2 diabetic patients and is more commonly seen in patients with type-1 diabetes.

Diabetic ketoacidosis is usually accompanied by high blood sugar levels. The FDA states that the reported cases “were not typical for DKA because most of the patients had type 2 diabetes and their blood sugar levels, when reported, were only slightly increased compared to typical cases of DKA.”

For individuals experiencing Farxiga ketoacidosis, the condition is quite unanticipated and, especially before the FDA warning was released, may not have been recognized as the reason for the symptoms some patients were experiencing. Symptoms of ketoacidosis include nausea, vomiting, confusion, stomach pain, difficulty breathing, unusual fatigue or sleepiness and fruity-smelling breath.

Farxiga ketoacidosis is a medical emergency that requires hospitalization. Typically, intravenous insulin is administered to bring down the level of ketones in the body and IV fluids are administered to keep patients hydrated and to rebalance blood chemistry. Untreated ketoacidosis can lead to passing out and in more severe cases, could cause a coma, which could result in death.

Have You Suffered From Farxiga Ketoacidosis?

If you have developed ketoacidosis as a result of having taken Farxiga to control your diabetes, you may be entitled to legal compensation. An attorney can provide you with a free consultation to review the details of your case and to inform you of the legal opportunities that are available to you should you choose to take legal action.