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SGLT2 Inhibitors

Type 2 diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, stop glucose from reentering the blood in the kidneys. These drugs are growing in popularity, but the FDA issued a number of warnings linking them to serious side effects like ketoacidosis, acute kidney injury and urinary tract infections that could lead to blood infections. Some patients may also file lawsuits against the drugs’ makers.

Did you take an SGLT2 inhibitor and suffer from ketoacidosis?You might be entitled to compensation.

Invokana and Invokamet

Invokana (canagliflozin) was the first SGLT2 inhibitor approved by the FDA. Manufactured by Johnson & Johnson's Janssen Pharmaceuticals division, Invokana hit the market in 2013 and quickly rose in popularity. J&J also spent $19.8 million marketing the drug to doctors in 2014, according to Bloomberg.

In 2014, the FDA approved Invokamet (canagliflozin and metformin).

SGLT2 Side Effects

Illustration of an Invokana bottle and a finger being pricked to check if levels are positive or negative

Invokana’s side effects range from yeast infections to more serious issues like diabetic ketoacidosis. In May 2015 the FDA issued a drug safety communication that warned patients and doctors that studies linked Invokana and Invokamet — and other SGLT2 inhibitors — to diabetic ketoacidosis (DKA).

Unlike other SGLT2’s, the FDA also found a link between Invokana and increased toe and foot amputations. The agency released a Drug Safety Communication in May 2016 and said it was investigating. Additionally, Invokana was not tested in pregnant women, but animal studies showed irreversible kidney problems in fetuses.

In 2016, the FDA also began investigating reports of acute pancreatitis linked to SGLT2 inhibitors. Acute pancreatitis occurs when the pancreas, the organ responsible for producing insulin, becomes swollen and inflamed. It can cause serious health issues if not treated and may even be fatal. Currently, the agency is "evaluating the need for regulatory action."

Invokana is available in 100 mg and 300 mg tablets. People with moderate renal problems should not take more than 100 mg daily, and doctors do not recommend Invokana for people with poor kidney function. Some side effects were more severe with higher doses.

Side effects linked to Invokana and Invokamet include:
Urinary tract infections Increased urination Thirst
Dry mouth Male and female yeast infections Constipation
Nausea Abdominal pain Fatigue
Loss of strength or energy Hypersensitivity (rash, swelling) Hypoglycemia
Diabetic ketoacidosis (DKA)

Farxiga and Xigduo

Farxiga (dapagliflozin) is a pill that patients take once daily with food. Xigduo (dapagliflozin and metformin) combines the active ingredient of Farxiga with metformin. It's the only SGLT2 inhibitor and metformin combination approved with a once-daily dosing.

The FDA approved Farxiga in 2014. The agency previously rejected it because of bladder and breast cancer concerns. It is not for treatment of Type 1 diabetes mellitus or for use in people with diabetic ketoacidosis.

Farxiga & Xigduo Side Effects

Farxiga's side effects range from common concerns such as nausea and back pain to more serious problems including urinary tract infections and bladder cancer. FDA studies of the drug — manufactured and marketed by Bristol-Meyers Squibb Co. and AstraZeneca — revealed people who take it may be five times more likely to develop bladder cancer, according to the Cancer Prevention & Treatment Fund.

In addition, research shows the drug could also promote a faster progression of bladder cancer in people who are already prone to the disease. So, people with bladder cancer should not take this drug.

Farxiga is available in two doses, 5mg and 10mg. Some side effects increased in patients taking a higher dose.

In addition, Xigduo XR also carries a black box warning for lactic acidosis, a condition caused by the build-up of lactic acid in the blood. Symptoms include nausea and weakness. These drugs should be used in conjunction with diet and exercise.

Side effects linked to Farxiga and Xigduo XR include:

  • Urinary tract infections (UTIs)
  • Genital fungal infections
  • Low blood pressure
  • Kidney problems
  • Diabetic ketoacidosis (DKA)
  • Back pain
  • Influenza
  • Nasopharyngitis (common cold)
  • Constipation
  • Hypoglycemia

Jardiance and Glyxambi

Jardiance (empagliflozin) is an oral medication marketed and sold by Boehringer Ingelheim approved in 2014. Glyxambi (empagliflozin and linagliptin) combine the active ingredients in Jardiance with the active ingredient in another Type 2 diabetes medicine called Tradjenta. Tradjenta belongs to a class of medications called DPP-4 inhibitors.

Like other SGLT2 inhibitors, these drugs are not for use in people with Type 1 diabetes or people with diabetic ketoacidosis.

Jardiance and Glyxambi Side Effects

One of the most common side effects of Jardiance is urinary tract infection. Some other troublesome problems reported in people who take this medication include male and female yeast infections, dehydration and hypoglycemia (low blood sugar). This drug also increases the amount of fat in the blood. In animal studies, the drug caused increased incidence of kidney and lymph node tumors in rats.

Jardiance is available in 10 mg and 25 mg tablets. Some side effects were more severe at higher doses. At higher doses, the drug caused birth defects in rabbit fetuses.

Glyxambi's side effects include pancreatitis (which can be fatal) and urinary tract infections.

Side effects linked to Jardiance and Glyxambi include:

  • Urinary tract infection
  • Genital yeast infections in men and women
  • Upper respiratory tract infection
  • Increased urination
  • Increased low-density cholesterol (dyslipidemia)
  • Nausea
  • Diabetic ketoacidosis (DKA)
  • Hypoglycemia
  • Kidney problems
  • Low blood pressure

FDA Safety Communications and Warnings

Only two years after the FDA approved Invokana, the entire SGLT2 inhibitor class of medications came under fire for serious side effects. The FDA released a number of warnings for potentially fatal side effects linked to these drugs beginning in May 2015.

After the FDA released these warnings, patients filed lawsuits for injuries they say an SGLT2 inhibitor caused. So far, there are no jury verdicts or settlements and the litigation is still in the early stages.

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  1. U.S. National Library of Medicine. (2016). JARDIANCE- empagliflozin tablet, film coated. Daily Med. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&audience=consumer#Section_5.4
  2. U.S. National Library of Medicine. (2014). FARXIGA- dapagliflozin tablet, film coated. Daily Med. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fc6ae30e-868b-4ac9-b69d-900922503998&audience=consumer
  3. FDA. (2015, May 15). FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
  4. FDA. (2015, December 4). SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm475553.htm
  5. FDA. (2016, May 18). FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm500965.htm
  6. FDA. (2016, June 14). FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm505860.htm
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