Jardiance Lawsuit in 2025 (Latest Updates)

Update: SGLT2 Inhibitor Drugs Linked to Flesh-Eating Genital Infections

August 29, 2018 – The FDA warns that type-2 diabetes drugs from the SGLT2 inhibitor class have recently been linked to a severe genital infection called necrotizing fasciitis of the perineum, also known as Fournier’s gangrene. The condition has been diagnosed in at least a dozen patients, all of whom required hospitalization and surgery, including one who died from complications.

SGLT2 Inhibitors Linked to Ketoacidosis

FDA is investigating the link between SGLT2 Inhibitors and dangerously high acid blood sugar levels. On May 15, 2015, the agency issued a warning that cited at least 20 cases of diabetic ketoacidosis (also known as DKA, diabetic acidosis, or ketoacidosis) in patients who took SGLT2 Inhibitors.

As claimed by this 2016 study from the FDA, the agency specified that all patients required hospitalization or admission to an emergency room to treat the problem. The median time to onset of symptoms was 2 weeks after initiating treatment with the drugs [1].

Diabetic Ketoacidosis Symptoms

• Problems breathing
• Nausea
• Vomiting
• Abdominal pain
• Confusion
• Unusual fatigue
• Sleepiness

Complications of Ketoacidosis

If ketoacidosis is not treated quickly, it can lead to:

• Fluid buildup in the brain (cerebral edema)
• Death of bowel tissue due to low blood pressure
• Heart attack
• Kidney failure
• Death

What is Jardiance?

Jardiance (generic: empagliflozin) is an oral diabetes medication that helps control blood sugar levels. The drug works by helping the kidneys remove glucose from the bloodstream.

According to the FDA, approved in August 2014, Jardiance belongs to a new generation of type 2 diabetes drugs called sodium-glucose co-transporter-2 (SGLT2) inhibitors. Other medications in this class include Invokamet, Farxiga (dapagliflozin), Glyxambi (empagliflozin and linagliptin), and Xigduo XR [2].

Jardiance Side Effects: What You Need to Know

Jardiance is a medication widely used for managing diabetes, but it can come with side effects. These range from mild to severe, requiring different levels of attention. Here’s a detailed breakdown based on urgency and severity to help you stay informed.

Serious Side Effects: When to Seek Immediate Help

Certain side effects of Jardiance are rare but can be life-threatening. Recognizing these symptoms early can make a critical difference.

• Diabetic Ketoacidosis (DKA):
  • Frequency: Rare
  • Symptoms: Nausea, vomiting, stomach pain, confusion, fruity-smelling breath, rapid breathing.
  • What to Watch For: Sudden onset of symptoms; check blood sugar and ketone levels regularly.
• Heart Attack (Myocardial Infarction):
  • Frequency: Very rare
  • Symptoms: Chest pain, shortness of breath, upper body discomfort.
  • What to Watch For: Unexplained chest pain or pressure.
• Kidney Failure (Renal Failure):
  • Frequency: Rare
  • Symptoms: Decreased urination, leg or ankle swelling, fatigue.
  • What to Watch For: Noticeable changes in urination or unexplained swelling.
• Fournier’s Gangrene (Necrotizing Fasciitis):
  • Frequency: Extremely rare
  • Symptoms: Pain, redness, swelling near the genitals or rectum, fever.
  • What to Watch For: Signs of infection in the genital area.
• Severe Allergic Reactions:
  • Frequency: Rare
  • Symptoms: Swelling of the face or throat, difficulty breathing, rash.
  • What to Watch For: Sudden swelling or trouble breathing.
• Blood Infections (Urosepsis):
  • Frequency: Very rare
  • Symptoms: Fever, chills, confusion.
  • What to Watch For: High fever or confusion signaling severe infection.
• Stroke:
  • Frequency: Very rare
  • Symptoms: Sudden numbness or weakness, confusion, difficulty speaking.
  • What to Watch For: Sudden neurological changes.

Moderate Side Effects: Consult a Doctor if These Occur

These side effects are less severe but still warrant medical attention if they persist or worsen.

• Kidney Infections (Pyelonephritis): Symptoms include fever, back pain, and painful urination. Watch for persistent urinary symptoms paired with fever.
• Severe Dehydration or Fluid Imbalance: Symptoms like dizziness, lightheadedness, and dry mouth may occur. Dehydration is especially common in hot weather or during illness.
• Hypersensitivity Reactions: Look out for rash, itching, or swelling. Contact a doctor if skin reactions develop after starting the medication.
• Bone Fractures and Abnormalities: Unexplained bone or joint pain could indicate underlying issues.

Common Side Effects: Monitor and Report if Persistent

These side effects are more frequent but usually less concerning. However, they should still be monitored, especially if they interfere with daily life.

• Urinary Tract Infections (UTIs):
  • Frequency: Common, affecting 17-18% of females.
  • Symptoms: Burning sensation during urination, frequent urination.
  • What to Watch For: Persistent symptoms that don’t improve.
• Fungal Infections:
  • Frequency: Common, affecting more than 5% of users.
  • Symptoms in Women: Vaginal itching or discharge.
  • Symptoms in Men: Redness or itching on the penis.
  • What to Watch For: Persistent itching or unusual discharge.
• Increased Urination:
  • Frequency: Common, affecting more than 5%.
  • What to Watch For: Excessive frequency disrupting daily routines.
• Abnormal Weight Loss:
  • Frequency: Common, affecting more than 5%.
  • What to Watch For: Significant and unexplained weight changes.

FDA Recommendation

In light of the risks associated with Jardiance and other similar diabetes medications, Healthcare professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms, the FDA said. Discontinue SGLT2 inhibitors if acidosis is confirmed, and take appropriate measures to correct the acidosis and monitor sugar levels.

Advisory Committee Recommends Approval of Jardiance for Cardiovascular Indication

June 29, 2016 – According to FiercePharma, an FDA advisory committee yesterday voted 12-11 that enough evidence exists to establish that Jardiance reduces cardiovascular (CV) death in adult type 2 diabetics with established CV disease [3].

Jardiance is the only oral type 2 diabetes drug shown in a clinical trial to reduce the risk of CV death. FDA now has to decide whether to follow the committee’s recommendation. While the agency is not obligated to take their advice, it usually does.

Jardiance in Heart Failure Patients: Key Research Findings

Jardiance has shown promising results in clinical trials for heart failure patients, particularly those with either preserved or reduced ejection fraction. Below is a breakdown of the key trials assessing Jardiance’s impact on heart failure and cardiovascular health.

1. EMPA-REG OUTCOME Trial: Impact on Cardiovascular Death in Type 2 Diabetes Patients

This large-scale trial focused on patients with Type 2 diabetes at high cardiovascular risk and aimed to evaluate Jardiance’s effect on cardiovascular-related death.

• Objective: To assess the effect of Jardiance on cardiovascular death in Type 2 diabetes patients with cardiovascular disease.
• Participants: 7,000 patients with Type 2 diabetes and cardiovascular disease.
• Duration: 3.1 years
• Key Findings:
  • 38% reduction in deaths from cardiovascular disease.
  • 32% reduction in overall mortality compared to placebo.
• Common Adverse Effects: Urinary tract infections, vaginal yeast infections, and hypoglycemia (especially when combined with insulin or sulfonylurea).

This trial demonstrated a significant reduction in mortality, confirming Jardiance’s potential benefits for patients with both diabetes and cardiovascular disease

2. EMPEROR-Preserved Trial: Addressing Heart Failure with Preserved Ejection Fraction (HFpEF)

The EMPEROR-Preserved trial was groundbreaking in evaluating Jardiance for heart failure with preserved ejection fraction (HFpEF), a condition with limited treatment options.

• Objective: To assess Jardiance’s effects on heart failure with preserved ejection fraction (HFpEF).
• Participants: 5,988 adults with HFpEF.
• Key Findings:
  • 21% relative risk reduction in cardiovascular death or hospitalization for heart failure.
  • 27% reduction in first and recurrent hospitalizations for heart failure.
  • Slowed decline in kidney function.
• Significance: Jardiance became the first successful treatment for HFpEF, addressing a major unmet need in cardiovascular medicine.

3. EMPEROR-Reduced Trial: Efficacy in Heart Failure with Reduced Ejection Fraction (HFrEF)

The EMPEROR-Reduced trial explored Jardiance’s effects in patients with heart failure and reduced ejection fraction (HFrEF), a condition with significant clinical challenges.

• Objective: To investigate Jardiance’s efficacy in heart failure with reduced ejection fraction (HFrEF).
• Participants: 3,730 adults with HFrEF.
• Key Findings:
  • 25% reduction in the composite endpoint of cardiovascular death or hospitalization for heart failure.
  • Demonstrated benefits across the full spectrum of heart failure.

This trial further strengthened the evidence supporting Jardiance as an effective treatment for heart failure, both in patients with preserved and reduced ejection fraction.

According to the Hans-Juergen Woerle, MD, global vice president of medicine, Boehringer Ingelheim, he said “The EMPA-REG outcome trial  demonstrated that Jardiance reduces the risk of cardiovascular death in diabetes patients at high cardiovascular risk, and we now look forward to exploring whether Jardiance can also provide heart failure benefits” [4].

4. New Safety Reports: Ketoacidosis and UTI Warnings

Despite its benefits, Jardiance has been associated with rare but serious side effects, prompting FDA action:

• Ketoacidosis Reports (February 1, 2016):
  • The FDA has received ongoing reports of diabetic ketoacidosis (DKA) in Jardiance users, with 12 cases reported between June 2014 and June 2015 [5].
  • Experts suggest the true number of incidences may be higher, as many adverse events go unreported.
  • Symptoms of DKA include nausea, vomiting, stomach pain, and fruity-smelling breath.
• FDA Warning Updates (December 4, 2015):
  • New warnings were added to Jardiance’s labeling, highlighting the risks of DKA and severe UTIs.
  • Patients are advised to stop using Jardiance and seek medical attention immediately if symptoms of these conditions occur.

Has There Been a Recall?

At this time, neither Jardiance nor any other diabetes medication from the SGLT2 inhibitor class has been recalled in the U.S. or any other country. The safety profile of these drugs is being investigated, and the agency is determining whether their labeling needs to be updated with information about their potential health risks.

FAQs

How can a lawyer assist in a Jardiance lawsuit?

A lawyer can assist by evaluating your case, gathering evidence, filing legal claims, negotiating settlements, and representing you in court. Their expertise ensures you receive fair compensation for your injuries and associated damages.

What should I do if I suspect Jardiance caused my health issues?

If you suspect Jardiance caused your health issues, consult with your healthcare provider, gather medical records, document your symptoms, and consult with a lawyer to evaluate your case and discuss potential legal action.

Are there alternative medications to Jardiance with fewer risks?

Yes, there are alternative medications to Jardiance that may have fewer risks. Consult with your healthcare provider to discuss other options for managing your condition and to find a medication that suits your health needs with minimal side effects.

See all related dangerous drug lawsuits our attorneys covered so far.

Do I Have a Jardiance Lawsuit?

The Product Liability & Defective Drug Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Jardiance lawsuits. We are handling individual litigation nationwide and are currently investigating potential settlement cases in all 50 states.

Free Confidential Case Evaluation: Again, if you or a loved one was injured by the side effects of Jardiance, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit against pharmaceutical companies and we can help.

References:

1. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm446994.htm
2. https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm446852.htm
3. https://www.fiercepharma.com/pharma/lilly-bi-narrowly-escape-panel-backing-for-jardiance-label-update
4. http://www.nejm.org/doi/full/10.1056/NEJMoa1504720
5. https://www.ismp.org/QuarterWatch/pdfs/2015Q2.pdf