Today Only The Invokana Drug Label Includes Warnings About Amputations Of Legs, Feet, And Toes; Will There Be Label Changes For Farxiga And Jardiance?
(Posted by Tom Lamb at DrugInjuryWatch.com)
Another new medical study indicates that lower extremity amputations is a drug class side effects of SGLT-2 inhibitor diabetes drugs such as Invokana, Jardiance, and Farxiga.
Earlier this month we reported that a medical study found that SGLT-2 inhibitors have a higher risk of leg, feet, and toe amputations when compared to older diabetes drugs such as sulfonylureas, metformin, and thiazolidinediones. An article setting forth the findings of this study was published online August 13, 2018 by the medical journal JAMA Internal Medicine
More recently, within the past week, a presentation at the 2018 European Society of Cardiology Congress in Munich, Germany included evidence that the SGLT-2 inhibitors Invokana, Jardiance, and Farxiga all are associated with twofold increases for lower-limb amputations when compared to GLP-1 receptor agonists diabetes drugs.
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From an August 25, 2018 Healio.com article, "SGLT2 inhibitor therapies may raise risk for amputation, diabetic ketoacidosis in diabetes with CVD", we get the following details:
In an observational study, [Peter Ueda, MD, PhD, from the department of medicine at the Karolinska Institute in Solna, Sweden,] and colleagues analyzed data from 17,213 patients without severe comorbidities who were prescribed any SGLT2 inhibitor, identified via nationwide registries in Sweden and Denmark. To reduce the risk for confounding by indication, Ueda said, researchers employed an active-comparator design with GLP-1 receptor agonist therapies, due to important shared features between the two drug classes in reducing CV risk and no known association for GLP-1 receptor agonists with the studied outcomes….
Within the SGLT2 inhibitor arm, 61% of patients were prescribed [Farxiga (dapagliflozin)], 38% of patients were prescribed [Jardiance (empagliflozin)] and 1% of patients were prescribed [Invokana (canagliflozin)].
Researchers observed a more than twofold increased risk for both lower-limb amputation and diabetic ketoacidosis for patients prescribed an SGLT2 inhibitor vs. a GLP-1 receptor agonist. For lower-limb amputation, the HR was 2.32 (95% CI, 1.37-3.91) for SGLT2 vs. GLP-1 receptor agonist use, with the largest absolute risk increases observed for those with a history of peripheral artery disease in the cohort (absolute risk difference, 14.9; 95% CI, 0.7-43.8), Ueda said.
We continue to investigate drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients who have had lower extremity amputations (legs, feet, toes) while using Invokana, Jardiance, Farxiga, or one of the other SGLT-2 inhibitors.
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