FDA Warns Invokana May Lead To Ketoacidosis
By: Marilyn McGoldrick, Esq.
The Food and Drug Administration recently issued a Drug Safety Communication warning doctors and patients that taking the new class of diabetes drugs known as SGLT2 inhibitors — including Invokana — may lead to high levels of blood acids called ketones, a serious medical condition called ketoacidosis. Diabetic ketoacidosis can cause a host of medical problems, and in the most severe cases can lead to a diabetic coma and death. Contact the Boston law firm of Thornton Law Firm LLP online or call us toll-free 888-491-9726 for a free Invokana consultation with a recognized leader in drug and medical device litigation.
Invokana and other sodium-glucose-cotransporter-2 drugs (SGLT2 inhibitors) work by causing excessive blood sugar to leave the body through the urine, lowering the body’s blood glucose levels. SGLT2s are prescribed to Type 2 diabetes patients and are popular because they also can lower blood pressure and make it easier for the patient to lose weight. SGLT2 inhibitors on the market include:
|Brand Name||Active Ingredients||Manufacturer|
|Invokana||Canagliflozin||Johnson & Johnson|
|Invokamet||Canagliflozin & Metformin||Johnson & Johnson|
|XigduoXR||Dapagliflozin & Metformin extended release||AstraZenica|
|Jardiance||Empagliflozin||Lilly & Boehringer-Ingelheim|
|Glyxambi||Empagliflozin & Linagliptin||Lilly & Boehringer-Ingelheim|
Johnson & Johnson’s Invokana, marketed in the U.S. by Janssen Pharmaceuticals, was the first SGLT2 approved by the FDA; it went on the market in March of 2013. In the first year that SGLT2 drugs were prescribed to diabetes patients, the Institute for Safe Medication Practices identified hundreds of complaints about users suffering serious side effects, including renal (kidney) failure or impairment; kidney stones, fluid/electrolyte issues, primarily dehydration; urinary tract infections, weight loss, hypotension (low blood pressure); and hypersensitivity.
In May 2015 the FDA warned that patients should be alert to the symptoms of ketoacidosis, and seek medical attention immediately if they experience “difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness” while taking SGLT2 diabetes drugs such as Invokana. The FDA has received over 20 complaints of ketoacidosis from patients taking SGLT2s:
“A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014 (see Data Summary). All patients required emergency room visits or hospitalization to treat the ketoacidosis. Since June 2014, we have continued to receive additional FAERS reports for DKA and ketoacidosis in patients treated with SGLT2 inhibitors.”
If you have taken Invokana or one of the other SGLT2 diabetes drugs and have experienced side effects, you should contact your physician immediately for diagnosis and treatment. If you have been diagnosed with ketoacidosis or any other serious side effects after taking Invokana or the other SGLT2 diabetes drugs, you may have a legal claim. Call the Invokana lawyers at Thornton Law Firm at our toll free number 888-491-9726 or contact us online for a free, no-obligation review of your case. Like all legal claims, there are strict time limits for taking legal action, so do not delay seeking legal advice.