Meanwhile Jardiance, Glyxambi, And Synjardy, Also In The SGLT2 Inhibitors Class Of Diabetes Drugs, May Help Slow Progression Of Kidney Disease In Patients At High Cardiovascular Risk
(Posted by Tom Lamb at DrugInjuryWatch.com)
In May 2016 this drug safety labeling change for Invokana (canagliflozin) was approved By FDA Center for Drug Evaluation and Research (CDER):
WARNINGS AND PRECAUTIONS
Acute Kidney Injury and Impairment in Renal Function
- INVOKANA causes intravascular volume contraction and can cause renal impairment. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving INVOKANA; some reports involved patients younger than 65 years of age.
Then on June 14, 2016 the FDA announced it has strengthened the existing warning about the risk of acute kidney injury for Invokana and Invokamet as well as Farxiga and Xigduo XR. Based on recent reports, the side effects warnings in the drug labels have been revised to include more exact information about acute kidney injury.
More precisely, from the Data Summary part of this document, "FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)", we get this detailed information:
A search of the FDA Adverse Event Reporting System (FAERS) database from March 29, 2013, to October 19, 2015, identified 101 cases of acute kidney injury with sufficient detail to confirm the diagnosis and demonstrate a temporal relationship with [(Invokana or Invokamet (canagliflozin)] (73 patients) and [Farxiga or Xigduo XR (dapaglifozin)] (28 patients). Hospitalization for evaluation and management of acute kidney injury was necessary in 96 of the 101 cases, and 22 cases involved admission to an intensive care unit. Four deaths occurred during hospitalization, 2 of which were cardiac-related. Fifteen patients received dialysis, and of these, 3 patients had a history of chronic kidney disease or previous acute kidney injury, and 6 reported concomitant use of both an angiotensin-converting enzyme (ACE) inhibitor and a diuretic. In 58 cases, the time to onset of acute kidney injury occurred within one month or less of initiating the drug.
The median age of the patients was 57 years (range 28-79 years). Among the 84 cases that reported an age, more than half were in patients who were 60 years or younger. Of the 101 cases, 51 reported concomitant ACE inhibitor use, 26 reported concomitant diuretic use, and 6 reported concomitant nonsteroidal anti-inflammatory drug (NSAID) use. A prior history of chronic kidney disease was reported in 10 of the 101 cases....
In the 78 cases reporting drug discontinuation, 56 cases reported improvement, demonstrating reversibility of this adverse event in a majority of cases. Eleven patients did not recover, which included the 4 deaths noted previously. Three patients recovered with sequelae upon discontinuation, suggesting that kidney injury may not be fully reversible in some situations.
Notably missing from this June 2016 drug safety warning were the drugs Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin), and Synjardy (empagliflozin and metformin hydrochloride), which are also included in the class of relatively new diabetes drugs known as Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors
This disparity might be explained by the recent finding that Jardiance, Glyxambi, and Synjardy may help slow progression of kidney disease in patients at high cardiovascular risk, according to a subanalysis of a large, international, industry-funded trial published in the New England Journal of Medicine (NEJM) and presented at the American Diabetes Association's meeting.
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For more on this drug safety development you can read this Original Article published June 14, 2016 by NEJM, "Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes", and this related NEJM Editorial piece, "Cardiac and Renovascular Complications in Type 2 Diabetes — Is There Hope?".
More generally, since the first Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitor was approved by the FDA in 2013, Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, and Synjardy, have been associated with these various drug side effects:
- Diabetic Ketoacidosis (DKA)
- Acute Kidney Injury
- Kidney Failure / Renal Failure
- Kidney Damage
- Heart Attacks / Myocardial Infarctions (MI)
- Ischemic Stroke / Cerebral Vascular Accident (CVA)
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Heart Failure
- Leg Amputation
- Foot or Toe(s) Amputation
- Bone Fractures
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients who have developed any of the medical conditions listed above.
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