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SGLT2 Inhibitors

Truth: SGLT2 inhibitors are supposed to lower blood sugar by enabling the kidneys to flush it out of your system.

Truth: They were approved by the FDA for use in patients with type 2 diabetes.

Truth: However, the FDA has warned of the risks of taking SGLT2 inhibitors that involve complications as severe as requiring amputations.

SGLT2 inhibitors can increase the risk of a variety of complications, including diabetic ketoacidosis, gangrene, infections from flesh-eating bacteria, kidney failures, and even the risk of foot and leg amputations. The FDA has known about these risks for years and has issued warning labels that include each of these risks.

If you have experienced complications as a result of being prescribed SGLT2 inhibitors to manage your diabetes, get help right away. We’ll fight for you against the companies that put profits above people’s health and safety. Contact us now for a free consultation – you pay nothing unless your case is successful.

What Are SGLT2 Inhibitors?

SGLT2 inhibitors are medicines (in pill form) that are prescribed (alongside diet and exercise) for lowering blood sugar in adults who have been diagnosed with type 2 diabetes. They work by making the kidneys flush out the sugar through urine. The FDA has approved SGLT2 inhibitors for type 2 diabetes patients but has not deemed them useful or effective for type 1 diabetes.

SGLT2 inhibitors get their name from the fact that they inhibit the sodium-glucose co-transporter-2. (SGLT2), which allows glucose to be reabsorbed by the kidneys.

Types of SGLT2 Inhibitors

SGLT2 inhibitors are also called gliflozin. The three medications that are qualified as SGLT2 inhibitors:

  • Canagliflozin
  • Empagliflozin
  • Dapagliflozin

They work by preventing the kidneys from reabsorbing the glucose, which is then removed from the body via urine, thereby lowering the body’s blood sugar level. All three types of gliflozin are approved by the FDA only for patients with type 2 diabetes mellitus, not for those with type 1 diabetes. They are also supposed to have cardiovascular benefits for people with type 2 diabetes.

Gliflozins are also commonly used as a secondary or tertiary treatment for type 2 diabetes because they are more expensive and have a shorter safety record than other available treatments.

Brands of SGLT2 Inhibitors

The three types of gliflozin are sold as the following brand-name medicines, including the Type of Gliflozin, the Brand Name and the Company:

  • CanagliflozinInvokana or Sulisent – Developed by Mitsubishi Tanabe Pharma and marketed by Janssen (a division of Johnson & Johnson)
  • Empagliflozin – Jardiance Boehringer Ingelheim & Eli Lilly
  • Dapagliflozin – Forxiga – Bristol-Meyers Squibb (in partnership with AstraZeneca)

Side Effects of SGLT2 Inhibitors

The most common side effects of taking SGLT2 inhibitors include:

  • Low blood sugar
  • Yeast infections
  • Urinary tract infections
  • Increased risk of developing diabetic ketoacidosis (DKA)

Diabetic Ketoacidosis

DKA, or diabetic ketoacidosis, is a complication of diabetes that usually occurs only in patients that have type 1 diabetes, but there is an increased risk of developing DKA in type 2 diabetes patients who take SGLT2 inhibitors. DKA occurs when the body doesn’t produce enough insulin, resulting in the body breaking down fat as fuel, depositing acids called ketones into the bloodstream.

The symptoms of diabetic ketoacidosis are:

  • Confusion
  • Excessive thirst
  • Frequent urination
  • Abdominal pain
  • Nausea
  • Vomiting
  • Weakness
  • Fatigue
  • Breath that smells fruity
  • Shortness of breath

There are further signs that DKA has developed that patients can test for at home:

  • High ketones levels in urine
  • Hyperglycemia (high blood sugar)

Ketoacidosis can be fatal, so if a patient experiences any of the above symptoms, they should immediately contact a doctor or go to the emergency room if the symptoms are multiple and/or severe.

Risks of SGLT2 Inhibitors

Risks of SGLT2 Inhibitors

In addition to common side effects, SGLT2 inhibitors can cause severe complications. Since the FDA first approved SGLT2 inhibitors in 2013, they have issued black box warnings for these risks. A black box warning label is one that the FDA requires to be printed on the packaging of the medication. This warning label for SGLT2 inhibitors has been updated several times over the years by the FDA as new risks of complications are discovered.

Risk of Bone Fractures

In 2015, the FDA updated the warning label for canagliflozin SGLT2 inhibitors, which include Invokana and Invokamet, to include information on the risk of bone fractures. The FDA had found that taking Invokana could increase the risk of having decreased bone density. Even if the bone density may not be low enough to be considered osteoporosis, there is still an increased risk of bone fractures as a result.

Risk of Urinary Tract Infections

Also in 2015, the FDA issued another updated warning to include the risk of severe urinary tract infections and increased amounts of acid in the blood (ketoacidosis). Developing either of these conditions can result in hospitalization, so patients exhibiting symptoms of either should stop taking their SGLT2 inhibitor medication immediately and consult with a doctor.

Symptoms of severe urinary tract infections include:

  • Frequent need to urinate
  • A burning sensation when urinating
  • Fever
  • Bloody or cloudy urine
  • Pelvic and/or abdominal pain
  • Urine that smells strongly

Risk of Amputations

The FDA has issued yet another update to the SGLT2 inhibitors’ warning labels to include the risk of amputations of the lower limbs. This risk is primarily associated with canagliflozin medications (Invokana and Invokamet). The FDA began a study in 2016 to investigate the risk and in 2017, confirmed that there is indeed an increased risk of amputations.

Signs to look out for include:

  • Pain or tenderness
  • Sores
  • Ulcers
  • Infections in the feet or legs

SGLT2 inhibitor-related amputations usually affect the toes more than the legs but can affect the entire leg, even above the knee. The FDA ran two studies, called CANVAS and CANVAS-R, and found in both that there was an increased risk for patients taking canagliflozin-based medication.

Study 1 (CANVAS) – Risk when taking Canagliflozin: 5.9/1000 patients

Study 1 (CANVAS) – Risk when taking a placebo: 2.8/1000 patients

Study 2 (CANVAS-R) – Risk when taking Canagliflozin: 7.5/1000 patients

Study 2 (CANVAS-R) – Risk when taking a placebo: 4.2/1000 patients

The study results above show a clear increase in the number of patients at risk for needing amputations among those taking canagliflozin as opposed to a placebo. This study resulted in SGLT2 inhibitors, especially the canagliflozin-based ones, added to an FDA watch list that medical practitioners and patients both are encouraged to report to if they experience severe side effects or complications of taking an SGLT2 inhibitor.

Risk of Kidney Failures

SGLT2 inhibitors, especially canagliflozin and dapagliflozin, carry an increased risk of injury to the kidneys. The FDA issued an updated warning in 2016 to include this risk of kidney failure. If the kidneys fail, this can cause dangerous levels of waste products, which are normally flushed out in urine, to build up in the body. If left untreated, kidney failure can be life-threatening.

Symptoms of kidney failure can include:

  • Fluid retention and swelling (usually in the ankles, feet, and legs)
  • Decreased output of urine
  • Fatigue
  • Weakness
  • Confusion
  • Nausea
  • Shortness of breath
  • Chest pain
  • Chest pressure
  • Irregular heartbeat

Risk of Flesh-Eating Bacterial Infections

Most recently, the FDA updated the SGLT2 inhibitor warning label in 2018 to include a warning for an increased risk of bacterial infections in the genital area. These infections are necrotizing fasciitis, or Fournier’s gangrene, which is the death of tissue in the area caused by a flesh-eating bacteria. It can be caused by urinary tract infections, which also have an increased risk from SGLT2 inhibitors.

Symptoms of Fournier’s gangrene are:

  • Fever
  • Dehydration
  • Anemia
  • Pain/swelling in the genital area
  • An unpleasant smell in the affected area
  • A crackling sound when the affected area is touched

SGLT2 Inhibitor Litigation

There are a variety of legal actions already taking place against manufacturers of SGLT2 inhibitors. Johnson & Johnson, whose Janssen subsidiary markets Invokana, a canagliflozin, over failure to adequately warn of the risks of taking SGLT2 inhibitors. A class action lawsuit in Canada alleges that the company failed to warn of the risks of kidney failure. In the United States, enough Invokana cases have accrued that a multi-jurisdiction case is going forward in federal courts.

Should I Consider an SGLT2 Inhibitor Lawsuit?

Have you experienced any of the following complications as a result of taking SGLT2 inhibitors to manage your diabetes?

  • Kidney failure
  • Toe or leg amputations
  • Fournier’s gangrene infection
  • Bone fractures
  • Urinary tract infections

If you believe your health complications to have been caused by the medication you’re taking, contact Farah & Farah now to speak with a highly qualified attorney experienced in medical lawsuits. Don’t wait to get the justice you deserve.

Co-counsel will be associated on these cases.