According to a story from FiercePharma, the US Food and Drug Administration (FDA) has recently ordered a total of 13 different diabetes drugs to begin carrying warning labels about the increased risk of a rare, flesh eating infection called Fournier’s gangrene. All of the drugs in question are of the SGLT2 type, and the agency has recorded about a dozen cases of this rare infection from patients using these drugs over the last five years.
About Fournier’s Gangrene
Fournier’s gangrene is a type of flesh eating infection that affects the external genitalia and perineum. It most frequently occurs in the older men, but it can affect women and children as well. Risk factors for Fournier’s gangrene include alcoholism, a weakened immune system, diabetes, and elevated blood sugar levels. Symptoms include weakness, swelling and pain of the affected area, fever, and skin damage. More severe cases may exhibit a foul stench and discharge of pus from the infection. This infection should be considered a medical emergency; treatment requires treatment with antibiotics and the removal of damaged tissue. The mortality rate of this infection is generally low with access to prompt, modern treatment. To learn more about Fournier’s gangrene, click here.
Elevated Risk
Almost all of the drugs have been directly connected to cases of Fournier’s gangrene. The only one that has not been directly tied to case of the infection is Steglatro, a SGLT2 drug developed by Merck that was approved last year. It will still receive the warning label since it is still a drug of this class.
The cases of Fournier’s gangrene all required hospitalization, and one of the patients died as a result of the disease. On average, the infection appeared about nine months after the beginning of drug use. Despite the clear connection between this serious infection and SGLT2 drugs, it is unlikely that this new warning will have a major impact on sales. A wealth of evidence continues to reinforce the effectiveness of SGLT2 inhibitors, which can reduce a diabetes patient’s risk of stroke, heart attack, and death from hospitalization. Drug makers hope to eventually expand the indication for this class of drugs.
