First approved by the FDA in 2013, sodium-glucose cotransporter 2 (SGT2) inhibitors help adults living with Type 2 Diabetes regulate blood sugar levels. Specifically, when combined with exercise and dietary changes, SGLT2 inhibitors release blood sugar – via the kidneys – into the urine. However, not long after the drug entered the market, patients started reported related cases of diabetic ketoacidosis, cardiovascular events and other life-threatening health concerns.
SGLT2 inhibitors encompass multiple medications:
- Invokana – active ingredient: canagliflozin
- Invokamet – active ingredients: canagliflozin and metformin
- Farxiga – active ingredient: dapagliflozin
- Xigduo XR – active ingredients: dapagliflozin and metformin extended-release
- Jardiance – active ingredient: empagliflozin
- Glyzambi – active ingredients: empagliflozin and linagliptin
- Synjardy – active ingredient: empagliflozin and metformin
Regardless of the combination, this class of drugs is associated with several severe side effects:
- Kidney failure
- Diabetic coma
- Organ failure
- Respiratory issues
- Cerebral and pulmonary edema
- Heart attacks
- Heart failure
- Blood clots
- Respiratory issues
Initially, drug labels omitted these side effects, until the FDA issued multiple warnings. Thus, doctors recommended them to patients without addressing all possible complications. As a result, patients given an SGLT2 inhibitor have started filing lawsuits against the drug manufacturers.
Ketoacidosis results when too much acid enters the blood, creating a chemical imbalance. For patients with diabetes, delaying treatment could result in a diabetic coma, brain swelling or even death. As a result, signs like breathing difficulty, nausea, abdominal pain or unusual fatigue require immediate medical attention.
After the FDA’s Database of Adverse Events identified 20 cases relating SGLT2 inhibitors to diabetic ketoacidosis, the organization released a Drug Safety Communication requesting that patients look out for all related symptoms. As a follow-up, the FDA later added that ketoacidosis stemming from SGLT2 inhibitor use could lead to a urinary tract infection which, if unchecked, may develop into urosepsis, a life-threatening blood infection; pyelonephritis, a kidney infection; or a genital mycotic infection.
Additionally, untreated diabetic ketoacidosis may cause patients to develop blood clots. The clots may then be behind a heart attack or stroke or could lead to other severe injuries within the body.
As another complication, diabetic ketoacidosis prevents the body’s cells from receiving the sugar they need to produce adequate energy. Essentially, the condition starves your cells and with time, the body begins to break down fat and muscle tissue for energy, releasing ketones into your blood in the process. As a result, the condition may cause organ and even bone damage.
In order for the body to release additional blood sugar through the urine, SGLT2 inhibitors place extra stress on the kidneys. While the drug appears to be working in the meantime and patients find their blood sugar under control, long-term use increases the chance of kidney failure.
Diabetic patients tend to develop narrower blood vessels and nerve damage, leading to reduced or no blood flow in the lower extremities, decreased pain sensation and difficulty recognizing wounds and ulcers in this area. An infection that develops here can thus lead to necrosis or gangrene, eventually requiring amputation.
Researchers have found that SGLT2 inhibitors, in fact, increase these complications by as much as 50 percent. Related amputations frequently involve the toes or part of the foot, although complications have been severe enough to warrant an above- or below-the-knee leg amputation. In response, the FDA has required multiple drugs in this class to display a black box warning.
A complication discovered more recently, SGLT2 inhibitor use may be linked with certain cancers. Researchers from the EMPA-REG OUTCOME Trial, published in September 2017, examined patients who took Invokana and Jardiance for at least six months. They found that subjects appeared to have double the risk of developing bladder cancer after this period, with higher rates in the Jardiance group.
From 2013 through May 2015, the FDA received 73 reports of diabetic ketoacidosis related to SGLT2 inhibitor use. By December, they released a warning and required all drug companies to update their labels. As well, Invokamet carries an additional black box warning for risks of lactic acidosis, a potentially fatal buildup of lactic acid in the body.
The next year, the FDA took the same approach after multiple reports surfaced of SGLT2 inhibitor-related acute pancreatitis.
By May 2017, the FDA required black box warnings concerning amputation risks. The decision came after a study indicating patients given drugs with active ingredient canaflozin had double the amputation risks as patients given a placebo.
As of 2018, no class action case concerning SGLT2 inhibitors exists. Rather, patients started filing individual claims against each drug manufacturer and courts have since consolidated these cases at the state level or into multidistrict litigation (MDL). Bellwether trials are expected.
Across all claims, plaintiffs and their attorneys allege drug manufacturers didn’t adequately warn patients and medical professionals about this class’ life-threatening and potentially fatal side effects and may have intentionally concealed these risks in order to boost profits. Plaintiffs further claim if they had been given all information right from the start, they would have selected another medication.
Did you develop diabetic ketoacidosis or another life-altering condition after being given an SGLT2 inhibitor? You may have a claim again one of this drug class’ manufacturers. To review your case and hold these parties accountable, bring your claim to our dangerous drug lawyers today.