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 because they are effective at lowering blood sugar, but the FDA issued a number of warnings linking them to serious side effects including diabetic ketoacidosis and blood and kidney infections.
If you took a diabetes drug like Invokana or Farxiga and suffered from amputation, ketoacidosis or kidney injury, you may be eligible for compensation.
Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a newer class of Type 2 diabetes medications. The first drug in this class was Invokana (canagliflozin), approved in 2013. After Invokana, a number of other SGLT2 inhibitors hit the market. Some also come in extended formulas and in formulas combined with metformin.
The drugs are rapidly growing in popularity. In the period between October 2014 and September 2015, doctors wrote 1.5 million prescriptions for Invokana or Farxiga (dapagliflozin), according to the FDA. Studies show they are effective in controlling excess blood glucose and lowering hemoglobin A1C — a measurement of blood sugar — in people with Type 2 diabetes. But potent blood sugar control also comes with side effects.
Beginning in December 2015, the FDA released a number of warnings linking these drugs to side effects, including some that can be fatal. Known SGLT2 side effects range from common ones like yeast infections to more dangerous, rare problems like diabetic ketoacidosis — too much acid in the blood. Clinical studies also found more dangerous possible health risks, such as increased bladder cancer risk.
Invokana is the most popular medication in this class, but there are two other FDA-approved SGLT2 inhibitors on the market along with various combination formulas.
These drugs work by preventing the kidneys from reabsorbing sugar and releasing it into the blood. The kidneys are powerful glucose filters. SGLT2 is a glucose transporter located in the proximal tubule of the kidneys. It reabsorbs 90 percent of glucose and returns it to the blood. SGLT2 inhibitors block this action of glucose reabsorption in the kidney. Instead of the glucose going back into circulation, the kidneys excrete it into urine.
A number of other Type 2 diabetes drugs affect the pancreas or insulin levels to control blood sugar. SGLT2s don’t act on insulin or the pancreas at all, and this makes SGLT2 inhibitors unique in how they work.
Depending on the pharmacy and insurance plan, patients’ cost for SGLT2 inhibitors vary. Higher doses may also cost more. Medication manufacturers may also offer special savings on prescriptions, and independent companies may offer drug discount cards. But in general, here is a list of all approved SGLT2 inhibitors and a cost comparison by number of tablets. These figures are only estimates.
Yeast infections and urinary tract infections (UTIs) are the most common side effects of SGLT2 inhibitors , occurring in roughly four to 11 percent of people who take the drugs. UTIs should be watched for signs of more serious complications since they can in rare cases develop into serious blood or kidney infections.
Clinical trials found at least nine common side effects that occurred in at least 2 percent of patients taking SGLT2 inhibitors along with minor side effects experienced by a smaller percentage of patients.
The FDA has required additional warnings added to some or all SGLT2 inhibitor labels on at least four occasions since first approving the drugs in 2013.
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); then it approved Invokamet XR in 2016.
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. In May 2017, the agency added a black box warning about the risk of foot and leg amputations. Additionally, there is limited data for Invokana in pregnant women, but animal studies showed irreversible kidney problems in fetuses.
Farxiga (dapagliflozin) is a pill that patients take once daily with or without food. Xigduo (dapagliflozin and metformin extended release) combines the active ingredient of Farxiga with metformin. The FDA approved Farxiga in 2014, and, shortly after, it approved Xigduo XR.
The agency previously rejected Farxiga 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 has the typical side effects of other SGLT2s, but clinical trials 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 active or prior history of bladder cancer should not take this drug.
Jardiance (empagliflozin), approved in 2014, is an oral medication marketed and sold by Boehringer Ingelheim. Glyxambi (empagliflozin and linagliptin), approved in 2015, combines 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. The FDA approved Synjardy in 2015. The drug combines empagliflozin with metformin. Like other SGLT2 inhibitors, these drugs are not for use in people with Type 1 diabetes or people with diabetic ketoacidosis. At higher dosages, animal studies showed that empagliflozin caused renal adverse effects. Jardiance should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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.
Please seek the advice of a medical professional before making health care decisions.
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