The FDA is warning that Jardiance has been linked to an increased risk of ketoacidosis (too much acid in the blood). The label on Jardiance has also been updated to include urinary tract infections that spread to the kidneys and cause kidney failure.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Jardiance induced injury cases in all 50 states. If you or somebody you know was diagnosed with a severe side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: Jardiance Linked to Genital Infections
In August 2018, the FDA issued a Safety Communication after 1 person died and 11 others were hospitalized with a severe genital infection called necrotizing fasciitis of the perineum (Fournier’s gangrene) after taking diabetes drugs in the SGLT2 inhibitor class.
What is Jardiance?
Boehringer Ingelheim manufactures Jardiance (empagliflozin), an oral medication for the treatment of type-2 diabetes. It is also sold in combination with linagliptin as the brand-name drug Glyxambi. In December 2016, it was also approved to reduce the risk of cardiovascular death in adults with type-2 diabetes.
How Does Jardiance Treat Diabetes?
When Jardiance was approved by the FDA in August 2014, it was the second drug in the sodium glucose co-transporter 2 (SGLT2) inhibitor class. It works by helping the kidneys remove sugar in urine, which reduces blood-sugar levels and helps prevent hyperglycemia.
Jardiance Side Effects
- Diabetic ketoacidosis
- Kidney infections
- Pyelonephritis
- Urosepsis
- Kidney failure
- Urinary tract infections
- Fournier’s gangrene (necrotizing fasciitis of the perineum)
Diabetes and Kidney Failure
People with type-2 diabetes are more likely to experience nephropathy, a kidney disease that occurs when excess sugar in the blood damages delicate structures. Because Jardiance forces the kidneys to excrete more sugar, some experts are concerned it might further increase these risks. In fact, the FDA has updated the label on Jardiance to warn about urinary infections that spread to the kidneys and cause kidney failure. Infections and dehydration, which are two of the most common side effects of Jardiance, can also lead to kidney failure.
FDA Safety Warning: Jardiance and Diabetic Ketoacidosis
In May 2015, an urgent Drug Safety Communication was issued for Jardiance after the FDA found dozens of reports of diabetic ketoacidosis. In December, the FDA updated the label on Jardiance to include ketoacidosis after receiving 73 reports of the side effect since March 2013.
Jardiance was not approved for most of this time period, but the FDA has continued to receive reports of diabetic ketoacidosis and they are concerned it could be a previously-unreported side effect. The FDA recommendation for patients on Jardiance:
“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 Health Agency Reports 101 Cases of Ketoacidosis Worldwide
There have been over 100 serious cases of diabetic ketoacidosis reported worldwide in patients on SGTL2 inhibitors, according to a new warning from the European Medicines Agency (EMA). Some of the victims had to be hospitalized and all cases were serious. Due to relatively mild symptoms, the EMA was concerned about delayed diagnosis:
“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.”
What is Ketoacidosis?
One of the most serious side effects of uncontrolled high blood-sugar is diabetic ketoacidosis, a condition in which there is too much acid in the bloodstream.
It occurs when the body starts burning fat as a fuel source rather than using glucose (sugar) in the bloodstream because it has too little insulin. This releases ketones, which are acidic toxins that build up in the body.
Hospitalization is usually required to treat diabetic ketoacidosis. Without treatment, the condition can progress to complications like cerebral edema, diabetic coma, and death.
Ketoacidosis Warning Signs & Symptoms
- Excessive thirst
- Frequent urination
- Nausea and vomiting
- Abdominal or stomach pain
- Fatigue
- Fruity-smelling breath
- Deep, rapid breathing
- Confusion
Jardiance Class Action
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.
Do I have a Jardiance Lawsuit?
The Schmidt Firm, PLLC is currently accepting Jardiance induced injury cases in all 50 states. If you or somebody you know was diagnosed with diabetic ketoacidosis, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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