FDA warns of link between SGLT2 inhibitors and serious genital infection

The FDA warned that SGLT2 inhibitors, which include AstraZeneca's Farxiga (dapagliflozin) and Eli Lilly's Jardiance (empagliflozin), have been linked with cases of necrotising fasciitis of the perineum, also referred to as Fournier's gangrene. The agency said that it is requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors.

According to the FDA, the condition developed in 12 patients within several months after they began taking the diabetes medicines between March 2013 and May 2018. The subjects were all hospitalised and underwent surgery for the condition, while one patient died. Meanwhile, the regulator noted that it found only six cases of Fournier's gangrene in a review of all other diabetes drug classes over a period of more than 30 years.

SGLT inhibitors, which also include Johnson & Johnson's Invokana (canagliflozin) and Merck & Co.'s Steglatro (ertugliflozin), are approved for use with diet and exercise to lower blood glucose in adults with type 2 diabetes. Jardiance is also authorised to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease.

The FDA noted that about 1.7 million patients received a prescription for one of the medicines from a retail pharmacy in 2017, with analysts estimating that the products will generate as much as $7.1 billion in sales by 2020.

In response to the warning, AstraZeneca said it is working with the FDA on updating Farxiga's label and noted that no cases of the condition had been seen during development of the drug.

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