New FDA Alert: A Dangerous Side Effect of Diabetes Meds
In a sharp turn of events, the FDA has issued a warning about a severe genital infection linked to a popular class of diabetes drugs known as SGLT2 inhibitors. The alert follows reports of one fatal case and 11 hospitalizations—including both men and women—over a period of five years.
What Are SGLT2 Inhibitors?
- First approved in 2013 to help lower blood sugar in adults with type 2 diabetes.
- Made by major pharma players—Johnson & Johnson’s Invokana, Eli Lilly’s Jardiance, Bristol‑Myers Squibb, AstraZeneca, Merck, and Pfizer.
Meet Fournier’s Gangrene: The Silent Menace
Fournier’s gangrene is a rare, but deadly bacterial infection that attacks the soft tissue around the genitals. It usually starts from a small cut and spreads rapidly, turning a simple skin issue into a life‑threatening crisis. Diabetes is a known risk factor, and the FDA has spotted a troubling link between this condition and SGLT2 inhibitors.
Key Numbers from the FDA
- 12 total cases reported from March 2013 to May 2018.
- 7 men and 5 women affected.
- 1 death; the rest required multiple, often disfiguring surgeries.
The infections appeared within a few months of patients starting an SGLT2 inhibitor, and in most cases, the medication was halted.
What’s Next?
The agency is pushing for these risks to be added directly to the medication labels—a move that could give doctors and patients a clearer picture of what to watch out for.
Pharma companies haven’t spoken back yet, but the FDA’s warning stands as a stark reminder: even the most well‑intentioned medication can have unexpected side effects. Stay informed, speak up with your healthcare team, and always keep an eye on your body’s signals.
