April 15, 2016 — A study published in Diabetes Care has found that 5-10% of people with type-1 diabetes who take insulin and Invokana developed ketone-related adverse events, including severe ketoacidosis that required hospitalization.
The researchers randomly assigned 351 diabetic people on insulin injections to receive Invokana (100-mg or 300-mg) or a placebo every day before breakfast. After 18 weeks, ketone-related adverse events were significantly more common in patients on Invokana:
- Any ketone-related adverse event: 5.1% of patients on 100-mg dose and 9.4% on 300-mg dose.
- Hospitalization for ketoacidosis: 4.3% of patients on 100-mg dose and 6% on 300-mg dose.
Five out of 12 patients who were hospitalized with ketoacidosis had blood-sugar levels below 13.9 mmol/L, which is the standard threshold for diagnosing ketoacidosis. The cases are unusual because ketoacidosis normally occurs along with very high blood-sugar.
The researchers also found that all of the patients who were hospitalized also had other risk-factors for ketoacidosis, including influenza, pneumonia, infusion-site infection, food poisoning, insulin pump failure/malfunction, noncompliance with insulin regimen, or decrease in food intake.
Last year, the FDA revised the label on Invokana to warn about the risk of diabetic ketoacidosis (DKA), a life-threatening condition in which the blood becomes too acidic. Invokana is not approved for people with type-1 diabetes, but it is sometimes prescribed “off-label” to help patients remove more sugar from their body in urine.
Between March 2013 and May 2015, the FDA received 73 reports of ketoacidosis in patients with type-1 or type-2 diabetes on Invokana. The FDA recommends:
“Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.”
Do I have an Invokana Lawsuit?
The Schmidt Firm, PLLC is currently accepting Invokana 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.
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