Jardiance, a type 2 diabetes medication made by Boehringer Ingelheim, has recently been linked to a adverse side effects including diabetic ketoacidosis (DKA), kidney failure, heart attack and more.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Jardiance, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Advisory Committee Recommends Approval of Jardiance for Cardiovascular Indication
June 29, 2016 – 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, according to FiercePharma. 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.
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. 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 Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Glyxambi (empagliflozin and linagliptin), and Xigduo XR (dapagliflozin and metformin extended-release)
SGLT2 Inhibitors Linked to Ketoacidosis
FDA is investigating the link between SGLT2 Inhibitors and dangerously high acid levels in the blood. On May 15, 2015, the agency issued a warning which cited at least 20 cases of diabetic ketoacidosis (also known as DKA, diabetic acidosis or ketoacidosis) in patients who took SGLT2 Inhibitors. All patients required hospitalization or admission to an emergency room to treat the problem, according to the FDA. The median time to onset of symptoms was 2 weeks after initiating treatment with the drugs.
- Problems breathing
- Abdominal pain
- Unusual fatigue
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,” FDA said. “Discontinue SGLT2 inhibitors if acidosis is confirmed, and take appropriate measures to correct the acidosis and monitor sugar levels.”
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
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.
“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,” said Hans-Juergen Woerle, MD, global vice president of medicine, Boehringer Ingelheim.
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 (PDF) published by the Institute for Safe Medication Practices (ISMP), at least 12 cases of ketoacidosis were associated with Jardiance in the 12-month period ending June 30, 2015. 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. Click here to learn more.
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
- 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.
Do I Have a Jardiance Lawsuit?
The Product Liability & Defective Drug Litigation Group at our 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 currently investigating potential settlements 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 suit and we can help.