The U.S. Food and Drug Administration (FDA) officials released a strong drug safety communication about the side effects of Invokana, Jardiance, Farxiga and similar diabetes drugs, causing serious genital infections. The infection is commonly referred to as a "flesh-eating" infection and is known as Fournier’s gangrene, a rare life-threatening condition, which kills soft tissues, muscles, and blood vessels. As per a 2006 study, if this condition is left untreated, it might lead to sepsis and organ failure soon.
The FDA has come across 12 cases of Fournier’s gangrene in patients under sodium-glucose cotransporter-2 (SGLT2) inhibitors treatment between March 2013 to March 2018. However, they indicate these figures are only from the reports submitted to the FDA, there might be more cases which the officials are unaware of yet. Drug Experts claim out of hundreds of adverse event incidents, only 10% or lesser reaches the FDA level.
Regulators at the FDA ordered new label warnings for drugs belonging to SGLT-2 class including Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet, and Steglujan. Steglatro is the only drug among these which is not linked to the genital infection, but the agency still requires a label warning anyway.
