Each of us will have different risk profiles so I think its fine that @tongMD finds the risk for SGLT2 inhibitors unacceptable; at age 30, that is not a completely unreasonable view of risk/reward thought it may be different than my own.
I think what we really want to focus on is trying to identify is the true likely range of the risk (Incidence per 1000, or 10,000, etc., and each person will make his or her own decision as to whether that risk is acceptable for them given the perceived potential benefit.
As stated, on this page the risk from the FDA is “reported” cases being 12 patients out of 1.7 million patients over 5 years from this document linked below. It seems possible, even likely, that this is not the full number of patients who got Fournier’s gangrene while taking SGLT2 inhibitors. Perhaps we want to use something like 170 patients as a worst case guess of the true number to be conservative. So - 170 over 1.7 Million over 5 years. This translates to 1 in 10,000 patients getting the disorder.
Some other points that are relevant:
- It typically starts within a few months of initiating the SGLT2 inhibitor - so it seems risk go down if you’ve been taking it for a year.
- Happens more frequently to men between age 50 and 79
Additionally, it suggests:
Publications report that Fournier’s gangrene occurs in 1.6 out of 100,000 males annually in the U.S., and most frequently occurs in males 50-79 years (3.3 out of 100,000).1-3 In our case series, however, we observed events in both women and men.
This number includes only reports submitted to FDA* and found in the medical literature,4-6 so there may be additional cases about which we are unaware. In 2017, an estimated 1.7 million patients received a dispensed prescription for an SGLT2 inhibitor from U.S. outpatient retail pharmacies.7 Although most cases of Fournier’s gangrene have previously been reported in men, our 12 cases included 7 men and 5 women. Fournier’s gangrene developed within several months of the patients starting an SGLT2 inhibitor and the drug was stopped in most cases. All 12 patients were hospitalized and required surgery.
A 1 in 10,000 risk is something that doesn’t really concern me too much. But for other people that may be an unacceptable risk. Thats fine - I’m not here to convince anyone, I’m just here to try to understand the potential risks and rewards as clearly as possible… and these types of discussions really help with that so I appreciate everyone’s input.
And, I’ll just keep this in mind:
Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.
And also to keep in mind the other risks I face on a regular basis:
| Lifetime odds of death for selected causes, United States, 2020 |
|
| Cause of Death |
Odds of Dying |
| Heart disease |
1 in 6 |
| Cancer |
1 in 7 |
| COVID-19 |
1 in 12 |
| All preventable causes of death |
1 in 21 |
| Chronic lower respiratory disease |
1 in 28 |
| Opioid overdose |
1 in 67 |
| Suicide |
1 in 93 |
| Motor-vehicle crash |
1 in 101 |
| Fall |
1 in 102 |
| Gun assault |
1 in 221 |
| Pedestrian incident |
1 in 541 |
| Motorcyclist |
1 in 799 |
| Drowning |
1 in 1,024 |
| Fire or smoke |
1 in 1,450 |
| Choking on food |
1 in 2,745 |
| Bicyclist |
1 in 3,396 |
| Sunstroke |
1 in 6,368 |
| Accidental gun discharge |
1 in 7,998 |
| Electrocution, radiation, extreme temperatures, and pressure |
1 in 14,705 |
| Sharp objects |
1 in 26,744 |
| Cataclysmic storm |
1 in 35,074 |
| Hot surfaces and substances |
1 in 50,341 |
| Hornet, wasp, and bee stings |
1 in 57,825 |
| Dog attack |
1 in 69,016 |
| Lightning |
Too few deaths in 2020 to calculate odds |
Sources:
