Synjardy controls blood-sugar levels with a combination of two medications, but unfortunately both can increase the risk of life-threatening side effects involving too much acid in the blood — diabetic ketoacidosis (DKA) and lactic acidosis.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Synjardy induced injury cases in all 50 states. If you or somebody you know has been diagnosed with 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 toll free 24 hours a day at (866) 920-0753.
What is the problem?
Synjardy combines metformin with empagliflozin. These medications control blood-sugar levels by forcing the kidneys to excrete more glucose (sugar) in urine, decreasing the amount of glucose absorbed by food, and increasing insulin sensitivity.
The problem is that empagliflozin has been linked to diabetic ketoacidosis (DKA), a condition involving too much acid in the blood. Synjardy also contains metformin and it carries a “Black Box” warning about lactic acidosis. This side effect occurs when lactate builds up in the body because cells are not getting enough oxygen.
FDA Safety Warning for Synjardy
In May 2015, the FDA issued a Safety Communication about the risk of ketoacidosis from Synjardy and all other diabetes drugs in the SGLT2 inhibitor class.
Synjardy patients should check ketone levels using urine test strips every few hours when they are at risk or ketoacidosis — especially during an infection, illness (cold, flu, etc.), injury, emotional stress, reduced food or water intake, or after recent surgery.
The FDA recommends that patients on Synjardy should be vigilant for symptoms of ketoacidosis and seek emergency medical attention if they appear. Blood-sugar levels may be normal or only slightly higher than normal. Other symptoms include:
- Abdominal pain
- Trouble breathing
- Unusual fatigue or sleepiness
What is the Risk?
Between March 2013 and May 2015, the FDA received 73 reports of patients who were hospitalized with ketoacidosis after taking a diabetes drug in the SGLT2 inhibitor class. Another report (PDF) specifically linked empagliflozin with 12 cases of ketoacidosis in 2015.
What is Ketoacidosis?
Ketoacidosis, also known as diabetic acidosis, occurs when toxins called ketones accumulate in the blood and body fluids. It is most often seen in people with uncontrolled diabetes who do not have enough insulin, which forces the body to burn fat for energy instead of using blood-sugar. This is called ketosis. When the liver metabolizes fats, it releases ketones. High levels of ketones make the blood too acidic and cause ketoacidosis.
Ketoacidosis causes increased urination, which further depletes electrolytes and fluid levels in the bloodstream. Without treatment, it can lead to diabetic coma (unconsciousness) and death, according to the American Diabetes Association.
Fortunately, acid levels are easily treatable. Patients who are hospitalized will likely receive intravenous (IV) fluids, electrolytes, minerals (potassium), and insulin to correct hyperglycemia if necessary. With treatment, long-term complications are rare and most patients go home in a day or two.
Do I have a Synjardy Lawsuit?
The Schmidt Firm, PLLC is currently accepting Synjardy induced injury cases in all 50 states. If you or somebody you know has been injured, 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 toll free 24 hours a day at (866) 920-0753.
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