Diabetic ketoacidosis is an emergency side effect of Synjardy that occurs when the blood becomes too acidic. The label on Synjardy also includes a “Black Box” warning about lactic acidosis.
Need a Texas Synjardy 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 ketoacidosis, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is the problem?
Synjardy is a combination of empagliflozin and metformin — two medicines that work in different ways to control blood-sugar levels in adults with type-2 diabetes.
Empagliflozin is a new member of a class of drugs called SGLT2 inhibitors. It blocks the kidneys from re-absorbing glucose as they filter blood, which results in more glucose being excreted from the body in urine.
The problem is that patients on Synjardy can develop two serious side effects involving too much acid in the body. One of these side effects is diabetic ketoacidosis (DKA), which can lead to diabetic coma (unconsciousness) or even death, according to the American Diabetes Association. Synjardy also has a “Black Box” warning about lactic acidosis, which is a side effect of metformin that occurs when cells do not get enough oxygen.
FDA Recommendation for Synjardy Patients
The FDA issued a Safety Communication about ketoacidosis from Synjardy in May 2015, and ordered stronger warning labels in December. According to the FDA, patients should stop taking Synjardy and seek medical attention immediately if they have any symptoms of ketoacidosis:
- Nausea
- Vomiting
- Abdominal pain
- Trouble breathing
- Confusion
- Unusual fatigue or sleepiness
How Many Cases Have Been Reported?
The agency said it had received 73 reports of ketoacidosis in patients on SGLT2 inhibitors. The Institute for Safe Medication Practices (ISMP) specifically linked empagliflozin with 12 reports (PDF) of acidosis in 2015.
Ketones & Ketoacidosis
Ketoacidosis, also known as metabolic acidosis, usually occurs when the body does not have enough insulin to use blood-sugar for energy. As a result, it must start burning fat reserves for energy. When the body metabolizes fat, the liver produces ketones, which are acidic toxins that can accumulate in the body and cause health problems.
What Should I Do?
People with diabetes should check ketones using a urine test trip or dipstick test — especially when you are at risk of ketoacidosis because you have an infection, missed a dose of insulin, are sick (vomiting or diarrhea), eating less food, not drinking enough water, stressed, injured, or recently had surgery.
How Is Ketoacidosis Treated?
Ketoacidosis is treated in a hospital, but most people recover without suffering any long-term complications. Intravenous (IV) fluids are usually necessary to correct dehydration. Patients may also receive vitamins (potassium), electrolytes, and insulin if their blood-sugar is elevated.
Need a Synjardy Lawyer in Texas?
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