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Table Of Contents
- Update: SGLT2 Inhibitor Drugs Linked to Flesh-Eating Genital Infections
- What is Jardiance?
- SGLT2 Inhibitors Linked to Ketoacidosis
- Diabetic Ketoacidosis Symptoms
- FDA Recommendation
- Complications
- Advisory Committee Recommends Approval of Jardiance for Cardiovascular Indication
- Studies to Evaluate Jardiance in Heart Failure Patients
- New Reports of Ketoacidosis in Jardiance Users
- FDA Adds Ketoacidosis, UTI Warnings to Jardiance Labeling
- Jardiance Side Effects
- Has There Been a Recall?
- FAQs
- Do I Have a Jardiance Lawsuit?
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.
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 [1].
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 [2].
Diabetic Ketoacidosis Symptoms
- Problems breathing
- Nausea
- Vomiting
- Abdominal pain
- Confusion
- Unusual fatigue
- Sleepiness
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.
Complications
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
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.
Studies to Evaluate Jardiance in Heart Failure Patients
May 2, 2016 – A pair of new outcome trials will look at the effectiveness of Jardiance for treating chronic heart failure, according to Healio. The trials are expected to begin within the next year and will evaluate heart failure patients both with and without type 2 diabetes.
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].
New Reports of Ketoacidosis in Jardiance Users
February 1, 2016 – The U.S. Food & Drug Administration (FDA) continues to receive reports of diabetic ketoacidosis (DKA) in patients treated with SGLT2 inhibitors like Jardiance.
According to the most recent QuarterWatch study published by the Institute for Safe Medication Practices (ISMP), at least 12 cases of ketoacidosis were associated with Jardiance in the 12 months ending June 30, 2015 [5].
Experts believe the actual number of incidences may be much higher, as many adverse events associated with a drug often go unreported.
FDA Adds Ketoacidosis, UTI Warnings to Jardiance Labeling
December 4, 2015 – A recent safety review has prompted the U.S. Food & Drug Administration (FDA) to add new warnings about the risk of ketoacidosis and severe urinary tract infections (UTIs) to the labeling of Jardiance and other SGLT2 inhibitor diabetes medications.
FDA advises patients to stop taking their SGLT2 inhibitor and seek immediate medical attention if they have symptoms of either condition.
Jardiance Side Effects
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Ketoacidosis)
- Heart Attack (Myocardial Infarction or MI)
- Kidney Failure (Renal Failure)
- Kidney Cancer
- Kidney Infections (Pyelonephritis)
- Kidney Stones
- Bone Fractures
- Bone Abnormalities
- Stroke
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
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:
- https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm446852.htm
- http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm446994.htm
- https://www.fiercepharma.com/pharma/lilly-bi-narrowly-escape-panel-backing-for-jardiance-label-update
- http://www.nejm.org/doi/full/10.1056/NEJMoa1504720
- https://www.ismp.org/QuarterWatch/pdfs/2015Q2.pdf
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