The FDA has recently updated the label on Jardiance to warn about life-threatening side effects like ketoacidosis (too much acid in the blood) and urinary infections that spread to the kidneys and cause kidney failure.
Need a Texas Jardiance Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with diabetic ketoacidosis or kidney failure, you should contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.
What is Jardiance?
Jardiance (empagliflozin) is a prescription medication for the treatment of type-2 diabetes. It is made by Boehringer Ingelheim and was approved by the FDA in August 2014. Another version is combined with linagliptin and sold under the brand-name Glyxambi.
How Does Jardiance Work?
Jardiance was the second FDA-approved drug in a new class called sodium glucose co-transporter 2 (SGLT2) inhibitors. It helps people with diabetes control their blood-sugar levels by helping the kidneys remove excess sugar in urine.
Jardiance Side Effects
- Diabetic ketoacidosis
- Kidney infections
- Kidney failure
- Urinary tract infections
Jardiance and Kidney Failure
Jardiance forces the kidneys to remove extras sugar from the body in urine, which is why it is not recommended for people with pre-existing kidney disease. The problem is that people with diabetes already have a higher risk of kidney damage (nephropathy) that develops after many years as the kidneys are damaged by excess sugar in the blood.
Jardiance may increase the risk of kidney failure in several ways. The FDA has recently updated the label to warn about kidney failure that can occur as a result of urinary infections that spread to the kidneys. Bacterial infections can also cause scarring and chronic kidney disease. Because Jardiance is a diuretic, it significantly increases the risk of dehydration, which can impair renal function.
Jardiance and Diabetic Ketoacidosis (DKA)
Jariance and other SGLT2 inhibitors were associated with a risk of diabetic ketoacidosis, a life-threatening condition involving too much acid in the bloodstream, in a Safety Communication issued by the FDA in March 2015.
Although SGLT2 inhibitors have only been on the market since March 2013, the FDA received 20 reports of diabetic ketoacidosis by June 2014 — and new cases continue to be reported.
The FDA was concerned because this side effect is normally associated with type-1 diabetes rather than type-2. Furthermore, all of the victims needed emergency medical treatment or were hospitalized.
Recommendation for Patients
In December 2015, the FDA updated the label on Farxiga to include ketoacidosis. Between March 2013 and May 2015, the agency received 73 reports of the side effect in patients on SGLT2 inhibitors. Click here to read more.
If you are taking Jardiance, the FDA recommends:
Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.
European Warning: 101 Cases of Ketoacidosis Reported
The European Medicines Agency (EMA) announced that 101 cases of diabetic ketoacidosis had been reported worldwide in patients on diabetes drugs in the SGLT2 inhibitor class. The EMA was particularly concerned about delayed diagnosis due to mild symptoms:
“Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased. These uncharacteristic blood levels could delay diagnosis and treatment.”
Diabetic ketoacidosis is a serious complication of diabetes that occurs when there is too much acid in the bloodstream. When the body cannot produce enough insulin, it starts burning fat to as a source of energy. The breakdown of fat cells releases ketones, which are toxic acidic waste products that build up in the body and cause complications. The condition is treatable in a hospital, but untreated cases can lead to cerebral edema (swelling in the brain), coma, and death.
Symptoms of Diabetic Ketoacidosis
- Excessive thirst
- Frequent urination
- Nausea and vomiting
- Abdominal or stomach pain
- Fruity-smelling breath
- Deep, rapid breathing
Jardiance Class Action Lawyer
Our lawyers are nationally-recognized class action attorneys, but we are not filing a Jardiance class action against Boehringer Ingelheim. Instead, we are filing individual lawsuits and only accepting cases involving the most serious types of injuries.
Need a Jardiance Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Jardiance lawyers for a free lawsuit review.