Case series / case reportcited by the Tayebat archiveabstract only checked★ key study A-ODD-12 in-depth review

Fournier gangrene reports with SGLT2 drugs

Fournier Gangrene Associated With Sodium-Glucose Cotransporter-2 Inhibitors: A Review of Spontaneous Postmarketing Cases.

Overview

Bersoff-Matcha SJ et al.. Ann Intern Med 2019 · PMID 31060053 · DOI 10.7326/M19-0085

FDA received 55 reports of this rare genital infection with SGLT2 drugs; reports cannot show how often it really happens.

Does the study support the specific claim? Partly · Methodological quality: very low

Study explained simply

What did the researchers want to find out?: Describe Fournier gangrene cases with SGLT2 inhibitors vs other agents
How was the study done?: Descriptive case series of FDA FAERS reports and published cases
How many people, animals or samples were studied?: 55 SGLT2 cases; 19 comparator cases; Adults with diabetes reported to FAERS
What was actually found?: 55 vs 19 reports.
How large was the observed effect?: not estimable
What do the results mean in everyday life?: Be alert to genital pain/swelling.
What are the study's limitations?: No incidence/causality; Reporting bias (stimulated reporting after warnings); Different time windows
What does it say about Elawady's specific claim?: Supports C-ODD-08 (signal).
Do the results apply to Germany and Europe?: FDA data; EMA issued similar warnings (not verified).
What can explicitly not be concluded from this study?: Incidence or causality.

Describe Fournier gangrene cases with SGLT2 inhibitors vs other agents

Study design: Case series / case report – Descriptive case series of FDA FAERS reports and published cases
Population: Adults with diabetes reported to FAERS
Country: USA
Period: 1984-2019
Sample size: 55 SGLT2 cases; 19 comparator cases
Inclusion and exclusion criteria: As described in the abstract; details not available in abstract.

Results: 55 cases (Mar 2013-Jan 2019), age 33-87, 39 men; all debrided; DKA 8, sepsis 9, AKI 4; 3 deaths. 19 cases with other agents 1984-2019 (metformin 8, glargine 6, short-acting insulin 2, sitagliptin+metformin 2, dulaglutide 1); 2 deaths.
Absolute risks: not estimable (no denominators)
Authors' conclusion: FG is a newly identified safety concern; physicians should be aware and suspicious early.

Counts cannot be compared as risks.

Supports C-ODD-08 (signal).

FDA data; EMA issued similar warnings (not verified).

Signal, not risk estimate.

Multidimensional assessment
Multidimensional assessment
Authenticity of the source	verified
Methodological quality	very low
Risk of bias	high
Precision of results	not applicable
Directness	direct
Reproducibility	not replicated
Consistency with the overall evidence	inconsistent
Regional transferability	high
Adequacy of the interpretation (by the archive)	partly correct but over-interpreted

None beyond those stated.

Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.

What the archive says about the study: FDA review: 55 Fournier-gangrene cases in SGLT-2 users 2013-2019 versus only 19 across all other diabetes drugs combined over 35 years; three deaths.
A. What was actually studied?: Describe Fournier gangrene cases with SGLT2 inhibitors vs other agents
B. What did the authors find?: 55 vs 19 reports.
C. What conclusions do the authors themselves draw?: FG is a newly identified safety concern; physicians should be aware and suspicious early.
D. What does the archive derive from it?: Used as proof of a large excess risk.
E. Is this derivation scientifically justified?: Numbers correct; comparing raw report counts over different periods is not a risk estimate, as the authors state.
Adequacy of the interpretation (by the archive): partly correct but over-interpreted