A “Black-Box Warning” about the increased risk of lower limb amputations was added to the drug labels for Invokana and Invokamet in July 2017.
Since that time there has been a mix of opinions expressed in the medical literature about whether or not lower limb amputations are a side effect of all diabetes medicines in the sodium-glucose co-transporter-2 (SGLT2) inhibitors class of drugs — which includes Farxiga and Jardiance — or limited only to Invokana and Invokamet.
This ongoing discussion, or controversy, is the subject of this December 5, 2018 piece, “The SGLT2 Inhibitor-Amputation Link”, by medical news reporter Judy George, from which we get the following excerpt:
There are several reasons why questions about SGLT2 inhibitors and amputations aren’t resolved, said Michael Fischer, MD, MS, of Harvard Medical School.
“One challenge in assessing this risk is that amputations are relatively rare events,” Fischer explained.
Although the Johns Hopkins analysis [which showed that starting treatment with SGLT2 inhibitors was tied to a significantly greater risk of amputations compared with new use of sulfonylureas, metformin, and thiazolidinediones (HR 2.12)] included a large number of patients treated with SGLT2 inhibitors, there were only 18 total amputations observed in that study, he noted….
For Fischer, the results from the randomized controlled CANVAS trial remain “the most reliable evidence that we have so far on the risk of amputation, and should be factored into clinicians’ prescribing decisions.”
It seems fair to say that the SGLT2 inhibitors drug class amputations side effect issue remains open to debate.
Over the past couple of years we have been contacted by patients who had lower limb amputations while using Farxiga, Jardiance, and other diabetes medicines in the SGLT2 inhibitors drug class other than Invokana and Invokamet. We are evaluating those amputation cases and possible drug injury lawsuits against the responsible pharmaceutical companies.[View article at original source]
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