This Class Of (Heavily Advertised) Drugs Includes Farxiga, Invokana, And Jardiance, Which Also Are Linked To Kidney Failure And Heart Attacks Or Myocardial Infarction
(Posted by Tom Lamb at DrugInjuryWatch.com)
In an earlier article, "Summer 2016 Update On Diabetes Medicines Invokana / Farxiga / Jardiance: Drug Label Changes And Safety Investigations", we pointed out that Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin), and Synjardy (empagliflozin and metformin hydrochloride) had a July 2016 label change for fatal cases of ketoacidosis, but several other diabetes drugs are known as Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors did not have a similar label change.
It turns out that this was only a matter of time, or timing. In August 2016 we saw FDA letters about approving and mandating a label change for ketoacidosis cases go out for the remaining diabetes medicines in this SGLT2 inhibitors class of drugs: Invokana (canagliflozin); Invokamet (canagliflozin and metformin); Farxiga (dapagliflozin); and, Xigduo XR (dapagliflozin and metformin extended-release).
For use as an example, here is the relevant part of an August 17, 2016 FDA Supplemental Approval letter to AstraZeneca Pharmaceuticals LP for Farxiga:
Please refer to your supplemental New Drug Application (sNDA) dated and received July 28 2016, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Farxiga (dapagliflozin) tablets.
We also refer to our letter dated July 8, 2016, notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for sodiumglucose cotransporter-2 (SGLT-2) inhibitors. This information pertains to the risk of fatal ketoacidosis.
The letter showed as Enclosure the Content of Labeling, which was not immediately available on the FDA's website on August 17 for review. But today we found the Farxiga "Revised 8/2016" Prescribing Information document -- which is commonly called the "drug label" by most people -- by using the DailyMed website (U.S. NATIONAL LIBRARY OF MEDICINE).
Here is the new ketoacidosis side effect warning from this revised Farxiga drug label:
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)].
Patients treated with FARXIGA who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of presenting blood glucose levels as ketoacidosis associated with FARXIGA may be present even if blood glucose levels are less than 250 mg/dL. If ketoacidosis is suspected, FARXIGA should be discontinued, the patient should be evaluated and prompt treatment should be instituted. Treatment of ketoacidosis may require insulin, fluid and carbohydrate replacement.
In many of the postmarketing reports, and particularly in patients with type 1 diabetes, the presence of ketoacidosis was not immediately recognized and the institution of treatment was delayed because the presenting blood glucose levels were below those typically expected for diabetic ketoacidosis (often less than 250 mg/dL). Signs and symptoms at presentation were consistent with dehydration and severe metabolic acidosis and included nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. In some but not all cases, factors predisposing to ketoacidosis such as insulin dose reduction, acute febrile illness, reduced caloric intake due to illness or surgery, pancreatic disorders suggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery), and alcohol abuse were identified.
Before initiating FARXIGA, consider factors in the patient history that may predispose to ketoacidosis including pancreatic insulin deficiency from any cause, caloric restriction and alcohol abuse. In patients treated with FARXIGA consider monitoring for ketoacidosis and temporarily discontinuing FARXIGA in clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or surgery).
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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 ketoacidois or any of the other medical conditions listed above while using Invokana, Farxiga, Jardiance, Invokamet, Xigduo, Glyxambi, or Synjardy.
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