In August 2016 the FDA sent letters to Janssen Pharmaceuticals and AstraZeneca Pharmaceuticals for label changes about fatal cases of ketoacidosis cases involving Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), and Xigduo XR (dapagliflozin and metformin extended-release).
As for the other diabetes drugs are known as Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class of drugs — Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin), and Synjardy (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals had received a similar letter for these three in July 2016.
From the “Revised 8/2016” Farxiga drug label, here is the start of this new ketoacidosis side effect warning:
5.2 Ketoacidosis
Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium-glucose cotransporter 2 (SGLT2) inhibitors, including FARXIGA. Fatal cases of ketoacidosis have been reported in patients taking FARXIGA. FARXIGA is not indicated for the treatment of patients with type 1 diabetes mellitus [see Indications and Usage (1.1)]….
Besides ketoacidosis there are other serious side effects associated with Farxiga, Invokana, Jardiance, and the several other diabetes medicines in this SGLT2 inhibitors class of drugs:
Acute Kidney Injury
Kidney Failure / Renal Failure
Kidney Damage
Pyelonephritis (kidney infection)
Urosepsis (blood infection)
Urinary Tract Infection (UTI)
Heart Attacks / Myocardial Infarctions (MI)
Ischemic Stroke / Cerebral Vascular Accident (CVA)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients who have developed ketoacidosis or any of the other medical conditions listed above while using Invokana, Farxiga, Jardiance, Invokamet, Xigduo, Glyxambi, or Synjardy.
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