At the recent American Diabetes Association (ADA) Scientific Sessions there were reportedly questions raised about whether there is an increased risk of Fournier’s gangrene when using Farxiga as well as other SGLT2 inhibitor diabetes drugs such as Invokana and Jardiance.
From this July 18, 2019 article published online by Medscape, “Fournier Gangrene and Genitourinary Infections With SGLT2 Inhibitors: ADA 2019 Update”, we get these details:
At the recent American Diabetes Association (ADA) Scientific Sessions, more details were presented on the adverse events in DECLARE-TIMI 58, the first trial of SGLT2 inhibitors completed after the FDA warnings on FG. The investigators planned to collect serious adverse events and any adverse events leading to drug discontinuation, but went back and did an in-depth check for necrotizing fascitis in light of the concerns.
They identified six cases of FG among study participants; five occurred in the placebo group (Table). Lawrence A. Leiter, MD, University of Toronto, Ontario, Canada, said in a press conference at ADA that on the basis of the DECLARE-TIMI 58 data, SGLT2 inhibitors do not seem to increase the risk and that FG is a diabetes-associated complication.
This Medscape article included a response to that contention by Susan Bersoff-Matcha, MD, of the FDA’s Center for Drug Evaluation and Research, who said the DECLARE-TIMI 58 data are still under review by the FDA. She went on to comment:
At this time, our opinion regarding the association between SGLT2 inhibitor use and FG has not changed. We, however, note that the DECLARE-TIMI 58 study only evaluated patients using [Farxiga (dapagliflozin)] and may not be reflective for the SGLT2 inhibitor drug class [as a whole].
We will continue to watch for evidence that Fournier’s gangrene is Farxiga side effect as well as Invokana, Jardiance, and other SGLT2 inhibitor diabetes drugs — or that it is not a drug side effect of these medicines.[Read article in full at original source]
Invokana / Farxiga / Jardiance
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