To date, most attention has been directed to the association between the sodium-glucose cotransporter-2 (SGLT2) inhibitors drugs and diabetic ketoacidosis (DKA).
More recently, there was an FDA announcement concerning a label change about the acute kidney injury side effect.
What has received less attention, it seems, is the fact that these still relatively new diabetes drugs — Invokana, Farxiga, and Jardiance, as well as their several “combination” products — have been linked to serious urinary tract infections (UTIs) that can result in more severe conditions, such as urosepsis and pyelonephritis.
For presenting some of the leading information about these side effects we turn to this source, “FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections”, issued on December 4, 2015.
From the “Safety Announcement” part of that document we get an introduction to this set of safety problems for Invokana, Farxiga, and Jardiance:
… symptoms of a urinary tract infection, such as a feeling of burning when urinating or the need to urinate often or right away; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine. Contact a health care professional if you experience any of these symptoms….
We also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.
And for the purpose of going more in-depth about the apparent increased risk of serious urinary tract infections (UTIs) associated with these SGLT2 inhibitor diabetes drugs, we get the following details from the “Data Summary” section of this December 2015 ‘FDA Drug Safety Communication:
A search of FAERS from March 2013 through October 2014 identified 19 cases of urosepsis reported with the SGLT2 inhibitors [Invokana (canagliflozin)] [n=10] and [Farxiga (dapagliflozin)] [n=9]). All cases resulted in hospitalization. No deaths were reported. Four patients required admission to the intensive care unit, and two required hemodialysis to treat renal failure. The median time to onset was 45 days (range 2 to 270 days). Discontinuation of the SGLT2 inhibitor was reported in 15 cases.
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients using SGLT2 inhibitor diabetes drugs who have developed side effects such as diabetic ketoacidosis, acute kidney injury, and serious urinary tract infections (UTIs) that led to urosepsis or pyelonephritis
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