These results suggest a very low increased rate which is unlikely to be statistically significant. These results are in contrast to data reported via the FDAs Adverse Event Reporting System (FAERS) which received 55 cases of Fourniers gangrene with SGLT2 inhibitors and potentially identified a new safety risk.
A related editorial highlights that policy makers should weight the comparative advantages and limitations of safety evaluations from various data sources, including FAERS, clinical trial data and observational data and determine how best to communicate this to healthcare professionals and patients when different sources do not arrive at the same conclusions.
A separate study found that of 228 DSCs from the FDA between 2010 to 2018 the most frequent information as the basis for the DSC was the FAERS (38%), and RCTs (36%).