SGLT2 Inhibitors Associated with Fournier
August 29, 2018 – The U.S. FDA has issued a safety alert regarding sodium-glucose cotransporter-2 (SGLT2) inhibitors, a class of medications used to treat type 2 diabetes. Patients who take SGLT2 inhibitors may be at risk of developing a rare but serious infection known as necrotizing fasciitis of the perineum, or Fournier’s gangrene.
Per the FDA, manufacturers must update the prescribing information and medication guides for their SGLT2 inhibitors to warn patients and healthcare professionals of the risk. The FDA also encourages patients to read the medication guide with each fill of an SGLT2 inhibitor to remain aware of any updates to the potential risks and benefits of the medication.
Symptoms of Fournier’s gangrene include swelling, redness, and tenderness that affect the genital and rectal areas, accompanied by fever or a general feeling of being unwell. Patients who experience these symptoms should seek medical help immediately, as the condition can worsen in a short amount of time. Physicians should assess patients for Fournier’s gangrene if they present these symptoms and begin immediate treatment with broad-spectrum antibiotics if the disease is suspected. Surgical debridement of affected tissue may also be necessary.
For patients who experience the disease, SGLT2 therapy should be discontinued and blood glucose carefully monitored. An alternative form of blood glucose control should be provided.
Patients and healthcare professionals can report instances of Fournier’s gangrene or other adverse effects that may be related to the use of SGLT2 inhibitors to the FDA’s MedWatch Program.