To Date, More Attention Paid To The Association Between These Sodium-Glucose Cotransporter-2 Inhibitors And Diabetic Ketoacidosis Or Acute Kidney Injury
(Posted by Tom Lamb at DrugInjuryWatch.com)
Over the past year the FDA has mandated several drug label changes for Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, and Synjardy, to increase the warnings about some serious side effects linked to these relatively new diabetes medicines. And the FDA is currently investigating additional adverse reactions that may be associated with these sodium-glucose cotransporter-2 (SGLT2) inhibitors drugs.
To date, most attention has been directed to the association between the SGLT2 inhibitors and diabetic ketoacidosis. For example, see this December 2015 article, "FDA Adds Ketoacidosis Warnings To Diabetes Drugs Invokana, Farxiga, And Jardiance As Well As Other SGLT2 Inhibitors".
More recently, there was an FDA announcement concerning a label change about the acute kidney injury side effect, as covered in this June 2016 article, "Invokana, Invokamet, Farxiga, Xigduo: Warnings About Acute Kidney Injury Risk Are Increased On Revised Drug Labels For These Diabetes Medicines".
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:
A U.S. Food and Drug Administration (FDA) safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization....
... 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.
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Next, we move to a part of that FDA document titled "Additional Information for Patients":
Serious Urinary Tract Infections
- Before taking an SGLT2 inhibitor, inform your health care professional if you have a history of problems urinating; or infections in the bladder, kidneys, or urinary tract.
- Contact your health care professional right away if you have any signs or symptoms of a urinary tract infection such as:
- A burning feeling when urinating
- A need to urinate often
- The need to urinate right away
- Pain in the lower part of your stomach area (pelvis)
- Blood in the urine
- Sometimes patients may also have a fever, back pain, nausea, or vomiting.
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. Details regarding whether or not there was a prior history of urinary tract infection was not available for most of the cases. Eight of the 19 reports documented blood culture results with E. coli as the isolated organism in each. Eleven cases contained no information about blood culture testing. There were no reports of fungal urosepsis. Details regarding the administered antibiotic agent, course of antibiotic treatment, and evidence of relapse or recurrent infection were not provided in any of the 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. For more information, see our Invokana / Farxiga / Jardiance / Invokamet / Xigduo / Glyxambi / Synjardy page.
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