Farxiga, Jardiance, And Other New SLGT2 Diabetes Drugs Also Cause Metabolic Acidosis As Well As Other Serious Side Effects
A new class of drugs for Type 2 diabetes that blocks the protein sodium glucose cotransporter 2 (SGLT2), in effect, lowers blood sugar by causing the kidneys to excrete some circulating glucose rather than return it to circulation.
These SGLT2 diabetes drugs are currently approved for use by patients in the US:
- Invokana (canagliflozin) — Janssen Pharmaceuticals — FDA Approval: 2013
- Invokamet (canagliflozin and metformin) — Janssen Pharmaceuticals — FDA Approval: 2014
- Farxiga (dapagliflozin) — AstraZeneca Pharmaceuticals — FDA Approval: 2014
- Xigduo XR (dapagliflozin and metformin extended-release) — AstraZeneca Pharmaceuticals — FDA Approval: 2014
- Jardiance (empagliflozin) — Boehringer Ingelheim Pharmaceuticals — FDA Approval: 2014
- Glyxambi (empagliflozin and linagliptin) — Boehringer Ingelheim Pharmaceuticals — FDA Approval: 2015
- Synjardy (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company — FDA Approval: 2015
According to data from IMS Health, Invokana, the first to win U.S. approval, reached 1.1 million dispensed outpatient prescriptions in the second quarter of 2015, followed by Farxiga with 411,000, and Jardiance with 136,000.
And from the ISMP QuarterWatch published January 13, 2016, with data from first and second quarters of 2015, an article presented some drug safety facts about these still relatively new diabetes drugs:
Adverse drug event reports over the last 12 months increased roughly in line with patient exposure, with 5484 new cases for [Invokana (canagliflozin)], 1805 for [Farxiga (dapagliflozin)], and 455 for [Jardiance (empagliflozin)]. We observed increasing numbers of reports of metabolic acidosis–a potentially life-threatening disorder that has been the focus of two FDA Drug Safety Communications. Over the past 12 months we identified 168 possible cases for [Invokana (canagliflozin)], 80 for [Farxiga (dapagliflozin)], and 12 for [Jardiance (empagliflozin)].
In turn, this caused the January 2016 ISMP QuarterWatch article to consider "Whether the clinical benefits of these drugs outweigh the increasing evidence of their risks remains uncertain."
Strictly Confidential, No Obligation.
As to why this drug safety concern is raised, from that same publication, in more detail:
SGLT2 inhibitor drugs in effect reprogram the kidneys in a fundamental manner. Normally kidneys regulate the fluid and electrolyte balance in the body and filter out waste proteins, but preserve circulating glucose. By blocking the kidney protein that transports sugar through the filtration membranes, the drugs cause some of the circulating sugar to flow instead into the bladder and be excreted in urine. However, the bladder and urinary tract normally do not have substantial concentrations of glucose and this change encourages the development of bacterial and fungal infections, especially in women. In clinical trials, [Invokana (canagliflozin)] was associated with genital mycotic infections in 11% of women and 4% of men over a 6-month period. This intervention causes other changes, some apparently positive, others not. It causes weight loss (around 4-6 pounds on the average) and lowers blood pressure by 1-2 mm Hg. On the other hand, it increases low density lipoprotein cholesterol (LDL-C), and impairs the glomerular filtration rates, both by small amounts on the average. Would these substantial changes result in a net benefit or harm over the long-term, life-long period of intended treatment? That pivotal question remains unanswered because longterm exposure has not been assessed in trials of sufficient size and duration. [footnotes omitted]
We have previously written several articles about Invokana, Farxiga, and Jardiance, as seen below:
- EMA Says Invokana / Farxiga /Jardiance Linked To Diabetic Ketoacidosis
- FDA Adds New Ketoacidosis Side Effect Warnings To Invokana Drug Label
- Invokana Label Gets New Warnings About Increased Bone Fracture Risks
- Despite Benefits Of Jardiance, There Are Still Safety Concerns
- Invokana Lawsuits Filed While FDA Investigates Side Effects Reports
- Farxiga / Jardiance / Invokana: Ketoacidosis and Kidney Failure
- Invokana / Farxiga / Jardiance: New Medical Study Finds A History Of Diabetic Ketoacidosis Events Is Associated With Increased Risk of Death
- May 2015 Diabetes Drugs – Ketoacidosis Link Warning By FDA Covers Invokana, Farxiga, And Jardiance, With Label Changes Possible
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients who have developed diabetic ketoacidosis, metabolic acidosis, kidney problems, or other serious side effects.
And be assured that we will be watching for additional drug safety warnings about Invokana, Farxiga, Jardiance, and these other new diabetes drugs.