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SGLT2 Inhibitor Lawsuits

diabetes drugsSGLT2 inhibitors first entered the U.S. diabetes drug market in March 2013. Sodium-Glucose Co-Transporter 2 is a protein that signals the kidneys to reabsorb sugar, so the new class of drugs works to lower blood glucose by stopping the absorption process, prompting the body to excrete sugar in urine instead.

Doctors liked SGLT2 inhibitors because they are effective in lowering blood pressure and levels of glycated hemoglobin in patients who cannot take metformin. Many type 2 diabetics also lose weight on the drug by excreting an additional 300 calories of sugar in the urine each day.

However, a recent safety communication issued by the U.S. Food & Drug Administration indicates there may be undisclosed risks associated with these newer diabetes treatments, warranting further investigation. Product liability attorneys at Edelman, Krasin & Jaye are offering case reviews with patients considering legal action based on health problems such as ketoacidosis allegedly caused by use of drugs like Invokana, Farxiga and Jardiance.

SGLT2 inhibitors

The list of SGLT2 inhibitors available to type 2 diabetes patients in the U.S. includes:

  • Invokana (canagliflozin)
  • Invokamet (canagliflozin and metformin)
  • Farxiga (dapagliflozin)
  • Glyxambi (empagliflozin and linagliptin)
  • Jardiance (empagliflozin)
  • Xigduo XR (dapagliflozin and metformin extended-release)

Sometimes doctors prescribe SGLT2 inhibitors off-label to type 1 diabetes patients as a way to lower metformin dosage.

Patients warned about adverse side effects

On the warning labels for SGLT2 inhibitors, manufacturers do mention a few known risks associated with their products. Farxiga, Jardiance and Invokana warning labels all state that vaginal irritation and urinary tract infections in women are the most common concerns. This side effect is present in as much as 10% of users, according to RXList.com, so anyone with a history of those health issues should weigh the pros and cons of treatment.

An increase in LDL cholesterol has also been observed in clinical trials, so patients who are at risk for a cardiovascular event will also need to discuss those risks with their doctor. Patients with existing renal issues are persuaded to avoid taking this medication, and doctors are encouraged to monitor patients for renal impairment, hypoglycemia and increased LDL cholesterol that may lead to heart attack or stroke.

According to manufacturers, risks of serious side effects — such as hypersensitivity, renal impairment and hypotension — increase with:

  • Age (75+)
  • Use of loop diuretics
  • Higher dosages (300 mg +)

While side effects are common with any drug, manufacturers are responsible for conducting thorough safety trials prior to releasing their drugs to the general public. They must also list all known risks that come up in pre-market trials and properly counsel doctors on how to best prescribe the drugs. If the warning labels prove inadequate, or known risks are concealed, patients could stand to receive substantial compensation by winning a product liability lawsuit or securing a settlement prior to trial.

Farxiga bladder cancer risks

The Farxiga labeling warns that 22 clinical studies “show a slight increase in bladder cancer risk” (0.17% versus 0.03% in placebos.) Yet, despite this disclosure, consumer watchdog groups like the National Research Center for Women & Families worry that manufacturer AstraZeneca isn’t being candid enough. President Diana Zuckerman called Farxiga “the worst new drug of 2014” and says that FDA studies found a 5x increased risk of bladder cancer among users, compared to diabetes patients on older drugs.

Ketoacidosis & SGLT2 inhibitors

On May 15, 2014, the US Food and Drug Administration (FDA) issued a safety communication stating that “the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.”

Patients suffering from ketoacidosis typically come down with something that feels like a horrible flu – with relentless vomiting, unquenchable thirst, muscle stiffness, fatigue and mental fog. They may have difficulty breathing, double over with abdominal cramps and feel confused. If left untreated, ketoacidosis could lead to heart attack, kidney failure or death.

The FDA Adverse Event Reporting System identified 20 cases of diabetic ketoacidosis requiring hospitalization from March 2013 to June 2014. All patients had been taking SGLT2 Inhibitors for about two weeks when the incidents occurred. The FDA says they “are continuing to investigate this safety issue” to determine if new warnings are needed. Other possible causes of ketoacidosis include: illness, dehydration, failing to eat or consuming too much fat and protein, or taking in too little insulin.

Invokana risks outlined by European Medicines Agency

SGLT2 inhibitors are sold both in the United States and abroad. In the European Union, the drugs are sold under the following brand names: Invokana, Jardiance, Synjardy, Ebymect, Edistride, Forxiga,Vokanamet and Xigduo. In February of 2016, the European Medicines Agency (EMA) issued a press release regarding the risks of ketoacidosis, which can develop in type 2 patients who still have normal blood sugar levels at the time of onset. The agency warns that this is an “atypical presentation,” and for patients to be aware of symptoms of high levels of blood acids, which can be life-threatening in nature.

Health regulators list the following as symptoms of diabetic ketoacidosis: stomach pain, extreme thirst, nausea, unusual sleepiness, rapid weight loss, confusion or a sweet smell to the breath. The EMA urges health care providers to consider diabetic ketoacidosis in patients who are taking SGLT2 inhibitors, regardless of their glucose test results. Furthermore, based on a review by the Pharmacovigilance Risk Assessment Committee (PRAC), the agency also recommends that patients temporarily halt the use of Invokana and other SGLT2 inhibitors while they are hospitalized for major surgery or illness.

Invokana and Farxiga litigation

Patients who suffer adverse side effects from this new class of diabetes drugs are encouraged to submit the details to the FDA adverse event reporting system. Beyond that, patients may have grounds for filing a personal injury lawsuit with the assistance of Edelman, Krasin & Jaye.

Janssen Pharmaceuticals has already been hit with a number of Invokana lawsuits alleging serious health problems ranging from kidney damage to complications arising from diabetic ketoacidosis. The defendant is charged with failing to adequately warn about potential risks and side effects of its drug and is being sued on counts of design defect, negligence, breach of implied and express warranty, fraud, negligent misrepresentation and unjust enrichment. Some plaintiffs are also demanding punitive damages in addition to actual and compensatory damages. Several claims have been brought in the U.S. District Court for the Eastern District of California, as well as Alabama and Illinois federal court.

Plaintiffs may be eligible for the following compensation:

  • Diminished earning capacity
  • Emotional distress
  • Funeral expenses
  • Loss of consortium
  • Lost wages
  • Medical bills
  • Pain and suffering

Edelman, Krasin, and Jaye – legal advocates you can count on

Our experienced attorneys will review your case free of charge. You only pay if your case is accepted and wins. So there is truly nothing to lose and everything to gain in launching an investigation into who is liable. Once the lawsuit has been filed, plaintiffs may have the opportunity to settle discreetly out of court or the case may go to trial before a judge and jury. If enough similar claims are filed around the country, the proceedings may be streamlined into a federal MDL. When this occurs, plaintiffs may be offered a settlement along with others or individual cases may be remanded back to the courts where they were filed for separate trials. The legal process could take years, so it’s important to contact an attorney to get started as soon as possible.

Call 1-800-469-7429 to arrange your consultation with veteran product liability lawyers at Edelman, Krasin & Jaye.

  1. Medline Plus – Diabetic Ketoacidosis http://www.nlm.nih.gov/medlineplus/ency/article/000320.htm
  2. Diabetes In Control – SGLT2 Inhibitors: A New Class of Diabetes Medications http://www.diabetesincontrol.com/articles/54-/14495-sglt2-inhibitors-a-new-class-of-diabetes-medications
  3. 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 http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
  4. Endocrine Web - SGLT2 Inhibitors and Diabetic Ketoacidosis: What's Behind the FDA Warning Product liability attorneys
  5. American Pharmacists Association - SGLT2 inhibitors for type 2 diabetes: Clinical considerations https://www.pharmacist.com/sglt2-inhibitors-type-2-diabetes-clinical-considerations