New Study Suggests Possible Drug Class Side Effects Of SGLT-2 Inhibitors Such As Invokana, Jardiance, And Farxiga
(Posted by Tom Lamb at DrugInjuryWatch.com)
Sodium-glucose cotransporter 2 inhibitors (SGLT-2 inhibitors) are relatively new medicines used to treat Type-2 diabetes. Included in this drug class are Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, Synjardy, Qtern, Steglatro, Steglujan, and Segluromet.
A new 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.
In more detail, this article "Association Between Sodium-Glucose Cotransporter 2 Inhibitors and Lower Extremity Amputation Among Patients With Type 2 Diabetes", by Hsien-Yen Chang, PhD, et al., was published online August 13, 2018 by the medical journal JAMA Internal Medicine.
Among the results stated by medical researchers involved with a recently concluded retrospective cohort study and reported in this medical journal article:
- [N]ew use of sodium-glucose cotransporter 2 inhibitors was associated with a statistically significant increased risk of amputation compared with use of metformin, sulfonylureas, and thiazolidinediones.
- New use of SGLT-2 inhibitors was statistically significantly associated with amputation compared with sulfonylureas, metformin, or thiazolidinediones (adjusted hazard ratio, 2.12; 95% CI, 1.19-3.77).
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For some commentary and observations about this recently concluded medical study we draw from a MedPage Today report, "Mixed Data on SGLT-2 Inhibitors' Amputation Risk":
"The rate of amputation found by Chang et al is strikingly lower than the rate found in the [Canagliflozin Cardiovascular Assessment Study (CANVAS)] program (6.3 per 1000 person-years), reflecting important differences between the populations in each study," commented Michael Fralick, MD, of Brigham and Women's Hospital in Boston, and two colleagues in an accompanying commentary, highlighting how the current study's population was generally younger, and fewer participants had a history of ischemic heart disease, history of amputation, or use of insulin compared with those in CANVAS.
"These differences in baseline comorbidities likely explain, at least in part, why the incidence rate of amputation was much lower than that detected in CANVAS," they suggested.
Interestingly in contrast, the recent OBSERVE-4D study reported new users on canagliflozin didn't have any increased risk for below-knee amputations when compared with other SGLT-2 inhibitors....
"The study by Chang et al helps to contextualize the risk in a relatively low-risk patient population, but does not settle the debate," expressed the commentators, stating how it's still unclear if this elevated amputation risk is attributed to a class effect with SGLT-2 inhibitors.
We have written previously about this apparent amputations side effect of these newer diabetes drugs:
- Jardiance – Lower Limb Amputations Drug Safety Issue Remains Uncertain
- Invokana – Amputations: No Explanation Yet As Regards “How” And “Why”
- FDA Reports Show Extent And Nature of Invokana-Amputation Side Effect
- Invokana Gets “Black-Box Warning” For Risk Of Leg And Foot Amputations
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients who have had lower limb amputations (legs, feet, toes) while using Invokana, Jardiance, Farxiga, or one of the other SGLT-2 inhibitors.
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