Update: FDA Panel Recommends Approval of Jardiance for Cardiovascular Indication
June 29, 2016 – An FDA advisory committee voted yesterday 12-11 that substantial evidence exists to establish that Jardiance reduces cardiovascular or CV death in adults with type 2 diabetes and established CV disease, according to Nasdaq. The recommendation was made by the Endocrinologic and Metabolic Drugs Advisory Committee based on data from the landmark EMPA-REG OUTCOME trial, which found that Jardiance significantly reduced the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke by 14% when added to standard of care in adults with type 2 diabetes and established CV disease.
Diabetes Drugs Linked to High Acid Levels: FDA Warning
According to an FDA Drug Safety Communication issued May 15, 2015, Jardiance and other diabetes medications in the sodium-glucose costransporter-2 (SGLT2) inhibitor class may cause a dangerous blood condition called diabetic ketoacidosis (also known as DKA, diabetic acidosis, ketoacidosis and metabolic acidosis), which can require emergency hospitalization.
“A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014,” FDA said. “All patients required emergency room visits or hospitalization to treat the ketoacidosis. Since June 2014, we have continued to receive additional FAERS reports for DKA and ketoacidosis in patients treated with SGLT2 inhibitors.”
Ketoacidosis Symptoms
- Difficulty breathing
- Nausea
- Vomiting
- Abdominal pain
- Confusion
- Unusual fatigue
- Sleepiness
FDA warns Jardiance users not to stop taking the medication without talking to their doctor first. The agency also warned healthcare providers to be on the lookout for the above symptoms in patients taking SGLT2 inhibitors.
Jardiance Side Effects
- Diabetic ketoacidosis (DKA, diabetic acidosis, ketoacidosis, metabolic acidosis)
- Heart attack
- Kidney damage / kidney failure
- Urinary tract infections (UTIs)
- Male and female yeast infections
- Low blood sugar (hypoglycemia)
- Bladder pain
- Bloody or cloudy urine
- Change in the color, amount, or odor of vaginal discharge
- Painful urination
- Frequent urge to urinate
- Pain during sex
- Anxiety
- Blurred vision
- Chills
- Cold sweats
- Confusion
- Dizziness / faintness
- Rapid heartbeat
- Headache
- Increased hunger
- Nausea
- Seizures
- Slurred speech
- Sweating
- Unusual tiredness or weakness
Has the Drug Been Recalled?
At this time, no recall has been issued for Jardiance or any other diabetes medication in the SGLT2 inhibitor class. However, black box warnings have been added to the labeling of Invokamet and Xigduo XR regarding the drugs’ potential to cause lactic acidosis. If users suspect this condition, they should go to the hospital immediately.
ISMP Reports on New Cases of Ketoacidosis in Jardiance Users
February 1, 2016 – SGLT2 inhibitors like Jardiance continue to be linked to reports of diabetic ketoacidosis (DKA), according to the most recent QuarterWatch (PDF) published by the Institute for Safe Medication Practices (ISMP). At least 12 cases of DKA were associated with Jardiance use during the 12-month period ending June 30, 2015. ISMP was unable to estimate the actual incidence of ketoacidosis among Jardiance users, as many cases likely go unreported.
Do I Have a Jardiance Class Action Lawsuit?
The Pharmaceutical 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 in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one has been injured by Jardiance side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.