In May 2015 FDA Issued A Warning That Invokana, Farxiga, And Jardiance Are Assoicated With This Serious Side Effect And Other Adverse Reactions
Invokana, Farxiga, and Jardiance are sodium-glucose cotransporter-2 (SGLT2) inhibitors, a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in patients with Type 2 diabetes.
From this March 17, 2016 MedPage Today report, "Canagliflozin in T1D Has Ketoacidosis Problem", we get a good overview of a recent medical study which found that an established Invokana side effect needs to be closely watched for when Invokana is prescribed "off-label":
Type 1 diabetes patients taking canagliflozin (Invokana) off-label were at a higher risk of of ketoacidosis than were those on placebo in a randomized trial.
The drug, an SGLT-2 inhibitor for patients with type 2 diabetes, was associated with a serious case of diabetic ketoacidosis (DKA) in five of 117 patients on 100 mg/day of the drug and in seven of 117 on 300 mg/day in an 18-week trial funded by Janssen, which markets the drug.
None of the 117 patients in the placebo group had DKA, reported Anne Peters, MD, at the University of Southern California, and colleagues in Diabetes Care.
After 18 weeks, the incidence of any ketone-related adverse event was 5.1% (n=6) in the 100-mg group and 9.4% (n=11) in the 300-mg group.
Because of the potentially life-threatening nature of DKA in patients with type 1 diabetes, further development of SGLT2 inhibitor therapy as a treatment for type 1 diabetes should proceed with caution," concluded the authors.
Among those who had serious adverse events, blood glucose levels varied from 9.4 to more than 44.4 mmol/L (170 to >800 mg/dL). There were no significant differences at baseline between the treatment and control groups that predicted a ketone related adverse event.
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For more detail we direct you to the underlying study as reported in this article, "Diabetic Ketoacidosis With Canagliflozin, a Sodium–Glucose Cotransporter 2 Inhibitor, in Patients With Type 1 Diabetes", published by the medical journal Diabetes Care on March 17, 2016.
From the Abstract for this article:
- OBJECTIVE To assess the incidence of serious adverse events (AEs) of diabetic ketoacidosis (DKA) with [Invokana (canagliflozin)], a sodium–glucose cotransporter 2 inhibitor, as an add-on to insulin in adults with type 1 diabetes.
- CONCLUSIONS [Invokana (canagliflozin)] was associated with an increased incidence of serious AEs of DKA in patients with type 1 diabetes inadequately controlled with insulin. Mitigation strategies are needed for use in future clinical trials to reduce the risk of DKA with [Invokana (canagliflozin)] treatment in patients with type 1 diabetes.
Diabetic ketoacidosis (DKA) is a state of metabolic acidosis brought on primarily by insulin deficiency. The condition can affect patients with type 1 or type 2 diabetes.
The symptoms of diabetic ketoacidosis can seem relatively benign to start — nausea, vomiting, weakness, fatigue, abdominal pain and excessive thirst could lead a person to suspect he or she has a particularly unpleasant case of the stomach flu.
But for a diabetic who is developing ketoacidosis, this serious medical condition can escalate quickly. Essentially, the patient's body, in need of insulin, turns to fat instead of glucose for energy. In turn, ketone bodies — molecules produced by the liver as an energy source from free fatty acids — accumulate in the bloodstream within hours. Ultimately, this build-up results in lower blood pH, causing a range of consequences from kidney failure and respiratory distress to coma or death.
We will continue to monitor this still-emerging drug safety issue and report significant developments here.