At The Recent American Diabetes Association (ADA) Scientific Sessions There Was An Expression Of Doubt About Warnings For This Association
(Posted by Tom Lamb at DrugInjuryWatch.com)
In August 2018 the FDA required a new warning about an increased risk of developing Fournier’s gangrene (also known as necrotizing fasciitis of the perineum) be added to the drug labels for all SGLT2 inhibitor diabetes drugs. That regulatory action was based on 12 cases of Fournier’s gangrene reported from March 2013 to May 2018.
Next, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued this Drug Safety Update, "SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)" in February 2019. This MHRA document included the following statement:
An [European Union (EU)] review has assessed reported cases of Fournier’s gangrene across the class of SGLT2 inhibitors. Although diabetes mellitus is a risk factor for the development of Fournier’s gangrene, some of the EU post-marketing reports were considered possibly to be related to the use of SGLT2 inhibitors. Fournier’s gangrene usually occurs almost exclusively in men. However, around a third of the EU cases reviewed were reported in women. We are also aware of rare occurrences of Fournier’s gangrene in patients on SGLT2 inhibitors in the USA (see FDA safety announcement).
Later, an FDA analysis article published in May 2019 by the medical journal Annals of Internal Medicine presented findings from a review of 55 cases reported to the FDA Adverse Event Reporting System (FAERS) through January 2019. Our article "FDA: More Reports Of Diabetes Drugs Invokana, Jardiance, And Farxiga Being Associated With Fournier’s Gangrene" covered this development.
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But just last month there was an expression of doubt about whether, in fact, Fournier's gangrene is a side effect of Farxiga, Invokana, and Jardiance as well as other less popular SGLT2 inhibitor diabetes drugs.
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.
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