Patients using the diabetes drugs Farxiga and Jardiance had twice the risk for lower limb amputations relative to certain other diabetes medicines, according to a new observational study published in November 2018 by The BMJ medical journal in.
However, in the US only a third diabetes drugs in the sodium-glucose cotransporter 2 (SGLT2) inhibitors class, Invokana, has a drug label warning for increased amputation risks, and it is a so-called “Black-Box” warning pursuant to an FDA mandate issued in May 2017.
By comparison, the European Medicines Agency (EMA) warned about a potential increased risk of lower limb amputations (mostly affecting the toes) in patients taking any of the SGLT2 inhibitors, including Farxiga and Jardiance as well as Invokana, in February 2017.
It is this BMJ article, “Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study”, which reports about Farxiga and Jardiance being associated with a two-times increased risk for amputations of toes, feet, and legs. Here is an excerpt from the Discussion part of this November 2018 medical journal article:
The twofold increase in risk of lower limb amputation associated with the use of SGLT2 inhibitors observed in our study is in line with the findings from the CANVAS Program, which randomised patients with high cardiovascular risk to [Invokana (canagliflozin)] or placebo. Importantly, our results were consistent in patients with and without cardiovascular disease and with and without peripheral arterial disease or previous amputation; the event rates, however, were substantially higher in the subgroups with such history. A pooled analysis of clinical trials of [Farxiga (dapagliflozin)] was underpowered to assess lower limb amputations, and no imbalance in this outcome in patients receiving [Jardiance (empagliflozin)] versus placebo was observed in the EMPA-REG OUTCOME trial. Whether the increase in lower limb amputations is a class effect for SGLT2 inhibitors, or specific to individual drugs, needs further study…. [Footnotes omitted.]
We will continue to monitor the drug safety issue of lower limb amputations for patients using Farxiga and Jardiance, in particular, as well as watch for a possible new FDA warning about an increased risk of amputations covering all SGLT2 inhibitor diabetes drugs, not just Invokana.[View article at original source]
Invokana / Farxiga / Jardiance
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