Farxiga Fails to Help Critically Ill Patients Suffering from Acute Organ Dysfunction: Study

A new study suggests that the diabetes drug Farxiga may be ineffective at treating patients with acute organ dysfunction, such as kidney injuries, raising concerns about the off-label use of the popular treatment.

Farxiga (dapagliflozin) was approved by the U.S. Food and Drug Administration (FDA) in 2014, as part of a new generation of diabetes medications known as sodium-glucose cotransporter 2 (SGLT-2) inhibitors, which also includes the blockbuster drug Invokana and Xigduo. The class generated sales of more than $10 billion in 2024, and are widely used by millions of Americans.

In findings published last week in the Journal of the American Medical Association (JAMA), a team of Brazilian researchers, led by Dr. Caio M. Tavares of the Hospital Israelita Albert Einstein, tested Farxiga to see if it could be used in intensive care units (ICUs) for the treatment of patients suffering from acute organ dysfunction. However, the drug failed to improve the patients’ outcomes.

For the study, Dr. Tavares and his team conducted a multicenter, randomized, open label clinical trial at 22 ICUs in Brazil involving more than 500 patients. All of the participants were unplanned ICU admissions suffering from at least one organ dysfunction involving the respiratory system, cardiovascular system, or the kidneys, who were hospitalized between November 22, 2022, and August 30, 2023. They followed up with those patients through September 27, 2023.

According to the findings, the length of time patients needed to stay in the hospital was about the same whether they received Farxiga or not. The data indicates 42.3% of patients given Farxiga had positive patient outcomes, compared with 41.9% among those who received standard care.

“There is increasing interest in SGLT-2 inhibitors for treating acutely ill patients. There is high-quality evidence to support their use in outpatients with diabetes, heart failure, and chronic kidney disease, and there is some potential benefit for patients with myocardial infarction,” Tavares and his team noted. “This trial was designed to extend the prior evidence and assess the effects of dapagliflozin in an unselected population of critically ill patients in a randomized trial”

However, they concluded that the addition of Farxiga to standard care for critically ill patients did not appear to improve clinical outcomes.

Farxiga Health Risks

The researchers noted that while Farxiga was well tolerated among the patients given it, it has been linked to severe side effects in the past.

In August 2018, the FDA issued a drug safety communication about the risk of Fournier’s gangrene from Farxiga, Invokana, and similar diabetes drugs. Incidents of the serious genital infections, also known as necrotizing fasciitis of the perineum, can result in the disintegration of flesh and can be life-threatening.

Over the last couple years, Farxiga in particular has faced a number of lawsuits over Fournier’s gangrene infections by former users of the diabetes drug, each raising similar allegations that users would have avoided the drug if earlier warnings and information had been provided about the potential risks.