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SGLT2 Inhibitors

diabetes drugsLeft uncontrolled, type 2 diabetes can lead to serious health effects like kidney damage, blindness, nerve damage, heart disease, and vascular disease. In March 2013, a new class of drugs called sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) was released with the promise of fewer side effects than earlier diabetes treatments while helping patients lose weight.

But use of SGLT2 inhibitors may be linked with ketoacidosis, a dangerous condition that has normally been a threat for type 1 diabetics but has typically not been seen in type 2 diabetics.

SGLT2 inhibitor uses

SGLT2-inhibiting drugs are novel because they work independently from insulin and are therefore less likely to lead to hyperglycemia.

Some of the other benefits that have led physicians to prescribe SGLT2 inhibitors are:

  • Weight loss
  • Reduction in levels of glycated hemoglobin (A1C)
  • Alternative treatment for patients who cannot take metformin (Glucophage)

SGLT2 inhibitors have become popular both as independent treatment and alongside other diabetes drugs and treatment.

How SGLT2 inhibitors work

Earlier generations of diabetes drugs worked by increasing insulin production or by lowering the body’s insulin resistance. But this new class of oral diabetes medications, SGLT2 inhibitors, work by preventing the re-absorption of glucose in the proximal renal tubules – in other words, they allow the kidneys to expel blood glucose with the urine rather than circulating back into the bloodstream. While taking a SGLT2 inhibitor has been shown to improve control over blood sugar and contribute to weight loss, the FDA warns that their use may cause diabetic ketoacidosis (DKA) – dangerously high levels of acid in the blood.

Side effects of SGLT2 diabetes drugs

These drugs work by increasing the concentration of glucose that passes through the urine.

They are associated with a number of side effects including:

  • Vaginal irritation
  • Urinary tract infections (UTIs)
  • Increased urination
  • Yeast infections
  • Loss in bone density

These side effects are most often seen within the first four months of use.

FDA safety communication regarding etoacidosis

According to a May 2015 safety communication by the U.S. Food and Drug Administration (FDA), the use of SGLT2 inhibitors may lead to diabetic ketoacidosis. According to the report, the FDA’s database showed 20 such cases between March 2013 and the beginning of June 2014. On average, the complications arose 2 weeks after beginning the medication. Each of those cases was so severe that hospitalization was required.

Ketoacidosis in type 2 diabetes sufferers is a dangerous and rare condition. DKA is a very real threat for patients with type 1 diabetes but is not usually seen in those with type 2 diabetes. In type 1 patients, diabetic ketoacidosis is typically seen only when glucose levels rise above 250 mg/dl. But for type 2 patients taking SGLT2 inhibitors, ketoacidosis has been seen in patients with blood glucose levels that are only mildly elevated, at less than 200 mg/dl.

Dangers of ketoacidosis

DKA is a build-up of ketones in the blood. Ketones are a by-products when the body burns fat, instead of glucose, for energy. As ketones build up, they poison the body and can cause a coma or even death.

Those taking an SGLT2 inhibitor should be aware of the symptoms of ketoacidosis:

  • Excessive thirst
  • Frequent urination
  • High blood sugar levels
  • Ketones in the urine
  • Fruity-scented breath
  • Dry or flushed skin
  • Unusual tiredness
  • Disorientation
  • Nausea, stomach pains, and/or vomiting
  • Difficulty breathing

DKA is very serious and any diabetic who experiences these symptoms should seek immediate medical care.

Drugs affected by FDA warning

There are currently three SGLT2 inhibiting drugs approved by the FDA. There are also three combination drugs that use the SGLT2 inhibitors along with other glucose-lowering agents.

Users of these drugs may be at risk of DKA and may be entitled to compensation if they suffer injuries caused by these medications.

Invokana [canagliflozin] – Johnson & Johnson’s canagliflozin was the first SGLT2 inhibitor approved by the FDA. It was seen to lower the risk of hypoglycemia (low blood sugar) compared to traditional diabetes drugs but, in addition to the risk of DKA, the FDA has warned that it may present a cardiovascular risk for users.

Invokamet  This combination of canagliflozin plus metformin is distributed by Johnson & Johnson’s Jannsen division. Metformin lowers glucose production while canagliflozin prevents the kidneys from circulating the glucose into the bloodstream. Invokamet should not be taken by anyone with severe kidney disease. Users may also be at risk of developing lactic acidosis, in which lactic acid accumulates in the bloodstream after glucose is broken down in the tissues.

Farxiga –[dapagliflozin] Manufactured by Bristol-Meyers Squibb and AstraZeneca. In 2012, the FDA rejected the drug on suspicion that it may contribute to liver damage, breast cancer, and bladder cancer. The FDA approved Farxiga in early 2014, requiring that the label warn users that taking Farxiga may worsen their cancer. It is also requiring that the manufacturer study another 17,000 diabetes patients to determine the long-term effects on cancer and liver and heart problems.

Xigduo XR – AstraZeneca’s combination drug of dapagliflozin and metformin hydrochloride extended release is a once-daily pill approved to treat type 2 diabetes in adults along with diet and exercise.

Jardiance – [empagliflozin] Manufactured by Eli Lilly and Company and Boehringer Ingelheim, this drug was approved in 2014 to treat adults with type 2 diabetes. The FDA has, however, required that the manufacturer conduct post-marketing studies on cardiovascular effects, toxicity in animals, and use for children.

Glyxambi  Eli Lilly and Company and Boehringer Ingelheim compound diabetes drug contains empagliflozin plus linagliptin. While empagliflozin helps prevent glucose from being reabsorbed into the bloodstream, linagliptin regulates the body’s level of insulin after meals. Glyxambi should not be taken by anyone with severe kidney disease.

An experienced pharmaceutical product liability attorney can advise people who have been injured while taking SGLT2 inhibitors if they are eligible to file a Farxiga, Jardiance or Invokana lawsuit.

  1. Medscape, Drugs for Diabetes: Part 8 SGLT2 Inhibitors,

  2. FDA, FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood,

  3. Medscape, SGLT2 Inhibitor Diabetes Drugs May Cause Ketoacidosis: FDA,

  4. American Diabetes Association, DKA (Ketoacidosis) & Ketones,

  5. Huffington Post, The Worst New Drug of 2014?,