This Follows October 2015 Safety Alert By Health Canada Concerning Increased Risks Of Kidney Problems
In December 2015 the FDA issued a Drug Safety Communication concerning the risk of ketoacidosis, a serious medical condition caused by having too much acid in the blood, for a class of newer diabetes drugs which include Invokana, Farxiga, and Jardiance.
From the Safety Announcement part of this FDA document, "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", we get this basic information about this ketoacidosis side effect:
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.
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. Patients should also be alert for signs and 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.
This latest FDA warning about the safety issues associated with this class of diabetes medicines follows an FDA announcement back in May 2015 about possible need for new drug side effects warnings. We reported about that development in this earlier article, "May 2015 Diabetes Drugs - Ketoacidosis Link Warning By FDA Covers Invokana, Farxiga, And Jardiance, With Label Changes Possible".
Just a couple of months ago, Health Canada pointed out that serious kidney or renal problems might be caused by Invokana and Farxiga (known as Forxiga in Canada). While it is not yet confirmed, all of the diabetes drugs in this class, such as Glyxambi, Synjardy, Invokamet, and Xigduo XR, may also be associated with kidney problems.
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In more detail, on October 16, 2015 Health Canada issued this advisory, "Summary Safety Review - Sodium Glucose Cotransporter 2 (SGLT2) Inhibitors INVOKANA (canagliflozin) and FORXIGA (dapagliflozin) - Evaluation of a Potential Risk of Acute Kidney Injury". This document provides these leading facts:
- This safety review of Invokana and Forxiga on acute kidney injury was triggered by new safety information received from the manufacturer of Invokana following the marketing of this product.
- Health Canada's safety review found a link between events of acute kidney injury and the use of Invokana and Forxiga.
- This safety review considered serious reports of acute kidney injury, acute renal failure and renal failure (severe renal impairment). These kidney problems occur when the kidneys suddenly become unable to filter waste products from the blood.
- At the time of the review, Health Canada had received two reports of acute kidney injury in Invokana users.
- Additional international reports of kidney injury suspected to be linked with either Invokana or Forxiga were provided by their Canadian manufacturers. The review of these cases showed that there was a link between events of acute kidney injury and the use of [Invokana and Farxiga / Forxiga].
- The review focused on Invokana and Forxiga, marketed since June 2014 and January 2015, respectively. Invokana and Forxiga use has been steadily increasing since the time of their marketing in Canada.
- A third SGLT2 inhibitor, Jardiance (empagliflozin) was marketed in August 2015. This product was not included in the review due to its recent approval; however, it already contains wording in its labelling for acute kidney failure (acute renal failure).
We are investigating cases of ketoacidosis, kidney damage / renal failure, and other serious side effects of Invokana, Farxiga, Jardiance, and these other newer medications for diabetes as possible drug injury lawsuits against the responsible pharmaceutical companies.