The Food and Drug Administration recently issued a Drug Safety Communication adding warnings to the labels of sodium glucose-cotransporter (SGLT2) inhibitors like Invokana alerting patients their diabetes medication may cause diabetic ketoacidosis or serious urinary tract infections. The FDA reports 73 cases of SGLT2 patients contracting diabetic ketoacidosis and 19 other instances where serious urinary tract infections caused blood or kidney infections, resulting in hospitalization.
Diabetic ketoacidosis is a serious, potentially life-threatening medical condition where the body fails to produce enough insulin to properly metabolize blood acids called ketones. Ketone build up can lower the pH of a patient’s blood and if left untreated, may result in diabetic coma or eventually death.
Symptoms of diabetic ketoacidosis include vomiting, nausea, confusion, abdominal pain, and heavy breathing. Patients may suffer from diabetic ketoacidosis even if their blood sugar levels are not very high.
According to the FDA’s Drug Safety Communication, there are 19 reported instances of SGLT2 inhibitor patients contracting blood infections (urosepsis) and kidney infections (pyelonephritis) that started out as urinary tract infections. As a result, new SGLT2 warning labels inform patients about the risk of developing serious urinary tract infections.
Signs of serious urinary tract infections are burning sensation during urination, frequent urination, abdominal pain, and blood in the urine. Patients sometimes experience fever, back pain, nausea, or vomiting as well.
SGLT2 inhibitors like Invokana are a class of medications designed to treat type 2 diabetes by forcing the kidneys to expel excess sugar through urination. The FDA first approved the sale and marketing of Invokana in 2013. In May 2015, the FDA issued a Drug Safety Communication warning patients taking Invokana and other SGLT2 inhibitors their diabetes medication may cause diabetic ketoacidosis.
In September 2015, the FDA issued a second Drug Safety Communication on Invokana warning patients the drug may lead to an increased risk of bone fractures. According to the FDA announcement, bone injuries were observed within the first 12 weeks of taking Invokana.
Some experts studying Invokana fear the type 2 diabetes drug may also put patients at an increased risk of suffering heart attack, stroke, or kidney failure. Studies into the subject are ongoing and may not be completed for years. In the meantime, patients may be put at an increased risk of suffering a serious, life-changing injury.
The Cochran Firm, D.C. has been actively monitoring the situation with Invokana since the FDA issued its first Drug Safety Communication about the type 2 diabetes drug in May 2015. As a law firm committed to consumer rights and helping injury victims, The Cochran Firm, D.C. is actively investigating Invokana kidney injuries and cases of diabetic ketoacidosis.
If you or a loved one suffered a serious injury while taking Invokana, contact The Cochran Firm, D.C. for a free legal consultation. You may be eligible for substantial compensation. Our attorneys can help your recover for your medical bills, lost wages, pain and suffering and other damages.