A recent safety review conducted by the U.S. Food and Drug Administration (FDA) has resulted in additional warnings being added to the labels of a specific class of type 2 diabetes medication known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.
The potentially dangerous prescription drugs can cause excessively high levels of acid in the blood, a condition known as diabetic ketoacidosis. The medications can also cause serious blood infections that stem from undetected kidney or urinary tract infections. Ketoacidosis, blood and kidney infections can result in hospitalization, permanent injury, and even death to diabetic patients.
SGLT2 inhibitors are a class of prescription medications that are FDA-approved to lower blood sugar in adults with type 2 diabetes. Medications in the SGLT2 inhibitor class include Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin). SGLT2 inhibitors are not currently FDA-approved for use in patients with type 1 diabetes.
FDA Conducts Report, Finds Startling Results
Following the completion of an Adverse Event Report in May 2015, the FDA issued a drug safety alert to warn physicians and patients about the risk of ketoacidosis and life-threatening infections while taking SGLT2 inhibitors.
From March 2013 to May 2015, FDA officials identified 73 cases of ketoacidosis in patients with type 2 diabetes who were being treated with an SGLT2 inhibitor. All 73 patients required hospitalization or emergency room treatment for complications associated with extremely high levels of acid in their blood.
Further adding to the complications, many patients were not immediately diagnosed with ketoacidosis, as their blood glucose levels were below what is typically seen in those afflicted with the condition. As a result, many patients suffered needlessly while waiting for an appropriate diagnosis and treatment.
In the report, the FDA also identified 19 cases of life-threatening blood infections and kidney infections as a result of unchecked urinary tract infections caused by an SGLT2 inhibitor.
All 19 patients required hospitalization, and some patients required admittance to an intensive care unit or dialysis center to treat kidney failure.
The FDA is urging any patient who experiences symptoms of ketoacidosis or kidney infections to stop taking their SGLT2 inhibitor and seek medical attention immediately.
Symptoms of ketoacidosis include:
- Nausea and vomiting
- Abdominal pain
- Difficulty breathing
Patients should also be aware of symptoms of urinary tract or kidney infections, which include:
- A burning feeling when urinating
- A constant need to urinate, or feeling like you need to urinate right away
- Pain in the lower abdomen or pelvic region
- Fever, chills, or blood in the urine
If you experience any of the above symptoms while taking an SGLT2 inhibitor, contact a health care professional right away.
New Warnings and Precautions for SGLT2 Inhibitors
As a result of the Adverse Event Report findings, the FDA has added new warnings to the labels of all SGLT2 inhibitors to alert patients to the drugs’ ability to cause ketoacidosis and blood or kidney infections, all of which can be life-threatening.
The FDA will also provide physicians with recommendations for prescribing SGLT2 inhibitors, as well as recommendations for monitoring a patient’s health while they undergo treatment with the drugs.
Additionally, the FDA is requiring all manufacturers of SGLT2 inhibitors to conduct research and to analyze data regarding reports of ketoacidosis and blood or kidney infections in patients taking SGLT2 inhibitors. Such research and information collection techniques are required for a period of 5 years.
If you or a loved one has suffered bodily harm as a result of a dangerous prescription drug, you may be entitled to compensation for medical expenses, lost wages, and pain and suffering.
Contact the defective product and dangerous drug attorneys at Schmidt Kramer today. We believe that all companies who fail to put consumer safety first need to be held accountable for their actions.