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By Heidi Turner
Lawyers are currently investigating Jardiance lawsuits, alleging patients were put at an increased risk of ketoacidosis and not adequately warned about the potential risk of Jardiance side effects. Both the Food and Drug Administration and the European Medicines Agency have warned about the risk of diabetic ketoacidosis in patients taking Jardiance and similar medications.
Jardiance (known generically as empagliflozin) was approved by the US Food and Drug Administration (FDA) in August 2014 to lower blood sugar in adults with type 2 diabetes. It is in a class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors, and works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.
In May 2015, the US FDA warned that Jardiance and other SGLT2 inhibitors (Invokana and Farxiga) could be linked to an increased risk of ketoacidosis, high levels of ketones (blood acids) that could require hospitalization. When the FDA made its announcement, it noted that from March 2013 to June 2014, the FDA had received 20 reports of diabetic ketoacidosis, ketoacidosis or ketosis in patients treated with SGLT2 inhibitors. All 20 patients required hospitalization or visits to hospital emergency rooms for treatment. Since that time, the FDA has received additional reports.
Patients are warned to watch for signs of ketoacidosis, including difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue. Patients with signs of ketoacidosis should seek medical attention immediately, but should not stop taking medication without speaking with a health care professional.
In June 2015, the European Medicines Agency (EMA) announced it was reviewing SGLT2 inhibitors, including Jardiance, to determine the risk of diabetic ketoacidosis. When it made the announcement, the EMA noted it had received 101 reports of diabetic ketoacidosis worldwide as of May 19, 2015. All 101 cases were considered serious, with some requiring hospitalization.
Ketoacidosis is a condition in which the patient' body has too much insulin and burns fat for fuel instead of sugar. Ketones, acidic toxins, build up in the body resulting in ketoacidosis. Diabetic ketoacidosis typically occurs in patients who have type 1 diabetes, making Jardiance and other SGLT2 inhibitor-related ketoacidosis unusual. Furthermore, the FDA reports that patients with type 2 diabetes who developed diabetic ketoacidosis had only slightly increased blood sugar levels, whereas diabetic ketoacidosis is usually accompanied by drastically elevated blood sugar levels.
When the EMA announced its review of SGLT2 inhibitors it noted, "uncharacteristic blood levels could delay diagnosis and treatment."
Patients who have taken Jardiance and developed ketoacidosis may be eligible to file a lawsuit against Boehringer Ingelheim, manufacturer of Jardiance, for failure to warn about the risk of ketoacidosis
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Patients are warned to watch for signs of ketoacidosis, including difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue. Patients with signs of ketoacidosis should seek medical attention immediately, but should not stop taking medication without speaking with a health care professional.
In June 2015, the European Medicines Agency (EMA) announced it was reviewing SGLT2 inhibitors, including Jardiance, to determine the risk of diabetic ketoacidosis. When it made the announcement, the EMA noted it had received 101 reports of diabetic ketoacidosis worldwide as of May 19, 2015. All 101 cases were considered serious, with some requiring hospitalization.
Ketoacidosis is a condition in which the patient' body has too much insulin and burns fat for fuel instead of sugar. Ketones, acidic toxins, build up in the body resulting in ketoacidosis. Diabetic ketoacidosis typically occurs in patients who have type 1 diabetes, making Jardiance and other SGLT2 inhibitor-related ketoacidosis unusual. Furthermore, the FDA reports that patients with type 2 diabetes who developed diabetic ketoacidosis had only slightly increased blood sugar levels, whereas diabetic ketoacidosis is usually accompanied by drastically elevated blood sugar levels.
When the EMA announced its review of SGLT2 inhibitors it noted, "uncharacteristic blood levels could delay diagnosis and treatment."
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