A U.S. Food & Drug Administration (FDA) review of a class of type 2 diabetes drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors has resulted in new warnings to the products’ labeling regarding serious urinary tract infections (UTIs) and too much acid in the blood (ketoacidosis). Affected medications include Invokana (canagliflozin), Farxiga (dapagliflozin) and Jardiance (empagliflozin).
Free Diabetes Drug Lawsuit Evaluation: If you were injured by a type 2 diabetes medication, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the problem?
The new labeling includes information about the risks of ketoacidosis and severe UTIs — both of which can lead to hospitalization if left untreated. The Warnings and Precautions section of the drug labels also provides prescribing and monitoring recommendations for healthcare providers.
On May 15, 2015, FDA issued a warning about the risk of ketoacidosis with SGLT2 inhibitors, indicating that the medications would be under continued investigation. A total of 73 ketoacidosis cases in SGLT2 inhibitor users were identified from the agency’s Adverse Event Reporting System (FAERS) from March 2013 to May 2015.
Additionally, at least 19 cases of urosepsis and pyelonephritis were identified from March 2013 to October 2014 that started as UTIs in diabetes patients taking SGLT2 inhibitors. All patients were hospitalized, and some were transferred to an intensive care unit (ICU) or dialysis to treat renal failure.
FDA is requiring manufacturers to perform a post-marketing study to look at cases of ketoacidosis in SGLT2 inhibitor users, including follow-up to obtain additional data for up to 5 years. Patients should discontinue SGLT2 inhibitor use and call their doctor immediately if they experience any symptoms of ketoacidosis such as nausea, vomiting, abdominal pain, fatigue or trouble breathing.
Healthcare professionals have been advised to assess for ketoacidosis and UTIs in patients with suggestive symptoms. Before initiating SGLT2 inhibitor treatment, clinicians should evaluate factors in patients’ histories that may increase the risk of ketoacidosis, including pancreatic insulin deficiency, caloric restriction and chronic alcohol abuse. SGLT2 inhibitor users who present with symptoms consistent with metabolic acidosis should be assessed for ketoacidosis, regardless of blood glucose levels.
Do I Have a Diabetes Drug Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in diabetes drug lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one has been injured by Invokana, Farxiga, Jardiance or other type 2 diabetes medication, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.