Jardiance – Lower Limb Amputations Drug Safety Issue Remains Uncertain

It appears there needs to more medical research done on the risk of lower limb amputations for patients who use the increasing popular diabetes medicines in the sodium glucose cotransporter 2 (SGLT2) inhibitor class, such as canagliflozin (Invokana / Invokamet), empagliflozin (Jardiance / Glyxambi / Synjardy), and dapagliflozin (Farxiga / Xigduo / Qtern).

And this remains true for Jardiance, despite these two medical journal articles published in November 2017:

1. “Cardiovascular Outcomes and Safety of [Jardiance (Empagliflozin)] in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease: A Subanalysis of EMPA-REG OUTCOME”, published in the American Heart Association’s journal, Circulation; and,
2. “[Jardiance (Empagliflozin)] and Assessment of Lower-Limb Amputations in the EMPA-REG OUTCOME Trial”, published in the American Diabetes Association’s journal, Diabetes Care.

The continuing uncertainty about whether Jardiance is associated with an increased risk of lower limb amputations is due to several reasons.

First, this apparent “soft” disclaimer about the findings of the medical researchers responsible for the Diabetes Care article about Jardiance and amputations:

We acknowledge the inherent limitations of manually identifying [lower limb amputation (LLA)] and performing post hoc analyses. A dedicated case report form was not used in the EMPA-REG OUTCOME trial as there was no concern regarding an increased risk of amputation with [Jardiance (empagliflozin)] before or during the trial. We are confident that the reporting and systematic retrieval processes employed were thorough.

Second, the November 27, 2017 Medscape story, “No Signal for Amputation With [Jardiance (Empagliflozin)] in EMPA-REG” which, despite the favorable title, included this cautionary part:

[D]octors are clearly still concerned about this and whether it represents a class effect of SGLT2 inhibitors or is specific to [Invokana (canagliflozin)].

Commenting on the topic in a recent perspective for Medscape Medical News, Harpreet Bajaj of Mount Sinai Hospital, University of Toronto, Ontario, said: “To reassure us of the benefit/harm balance with [Invokana (canagliflozin)], we clinicians need more data-mining from CANVAS and additional long-term randomized controlled trials.”

Third, only five months ago, a leading expert in diabetes medicine made this observation in this June 2017 Forbes article, “J&J Drug Prevents Heart Attacks At Cost Of Amputated Toes”:

John Buse, the chief of endocrinology at UNC – Chapel Hill provided his opinion on the matter, “Personally, I would much rather have a small heart attack than lose a toe… And I think I would much rather have a big heart attack than lose a leg.” He anticipates a significant debate, saying that the benefits and harms are most likely “over- and under-estimated in each study.”

We are monitoring the medical literature for further developments concerning the risk of lower limb amputations and diabetes medicines in the SGLT2 inhibitor class of drugs, such as Jardiance, Invokana, and Farxiga.

Invokana / Glyxambi / Synjady

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