Jardiance Combo Drug Approved by FDA, As Investigation into Ketoacidosis Risk Continues

Even as the FDA continues to investigate a potential risk of ketoacidosis from Jardiance and other new-generation diabetes drugs from the same class of medications, a new combination therapy has been approved by the agency that includes both Jardiance and the older diabetes drug metformin. 

Eli Lilly and Boehringer Ingelheim announced late last month that the FDA has approved Synjardy as the latest medication in a new class of type 2 diabetes medications, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. The Jardiance combo drug contains the widely used first-line diabetes treatment metform and empagliflozin, the active ingredient in Jardiance

The approval came just days after the companies issued a press release indicating that a long-term clinical trial demonstrated that Jardiance reduced the risk of cardiovascular death, non-fatal heart attacks and strokes. However, the entire new class of diabetes drugs has been linked to concerns in recent months about a potential diabetic ketoacidosis risk, after users reported suffering serious complications associated with elevated levels of acid in the blood.

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Jardiance and other SGLT2 inhibitors work in a different way from older diabetes drugs, removing excess glucose from the body through the urine by preventing the kidneys from absorbing it. Invokana was the first member of this class, introduced in March 2013, and is also the most widely used. However, other SGLT2 diabetes drugs include Invokamet, Farxiga, Glyxambi and Xigduo XR.

In May 2015, the FDA issued a warning about the ketoacidosis risk with Invokana, Farxiga, Jardiance and other SGLT2 inhibitors, indicating that more than 20 adverse events were received by the agency during the first 15 months the class of medications was on the market in the U.S. All of the reports involved individuals diagnosed with diabetic ketoacidosis, acidosis or ketosis following use of the medications, which resulted in emergency room treatment or hospitalization.

Ketoacidosis occurs when high levels of blood acids, known as ketones, build up in the blood. This can result in symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring urgent medical treatment and potentially resulting in severe health consequences.

Although diabetic ketoacidosis is commonly associated with type 1 diabetes, it is not normally seen among individuals diagnosed with type 2 diabetes, which is the type of diabetes Jardiance and the other drugs are approved to treat. Type 2 diabetes is an acquired and curable condition, while type 1 diabetes is usually something someone is born with and persists for life.

A growing number of lawyers are now reviewing potential Jardiance lawsuits, as well as Invokana lawsuits, Farxiga lawsuits and claims involving other members of the class, for individuals hospitalized due to ketoacidosis. Plaintiffs claim that the drug makers failed to adequately research the potential side effects before aggressively marketing the new generation diabetes treatments.

Potential claims are also being investigated for individuals diagnosed with a kidney injury from Invokana or another related diabetes treatment, as a large number of adverse event reports have also been submitted involving complications like kidney failure, kidney impairment, kidney stones, urinary tract infections and other injuries that may be associated with the unique mechanism of action for the drugs, which impact the normal function of the kidney.


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