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.
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.
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
Heart Attacks / Myocardial Infarctions (MI)
Ischemic Stroke / Cerebral Vascular Accident (CVA)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Foot or Toe(s) Amputation
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.[Read this article in full at original source]
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