The TGA is investigating whether patients need to be warned about a horrific – but extremely rare – adverse event associated with SGLT2 inhibitors.
The move follows regulatory action in US after a dozen people taking SGLT2 inhibitors contracted genital gangrene requiring surgery in the past five years.
One patient died, while others underwent multiple disfiguring surgeries to treat the disease, the FDA said.
The FDA issued a warning about SGLT2 inhibitors in August and is now requiring manufacturers to list the rare infection as a potential adverse event in prescribing and patient information sheets.
To date, the TGA had not received any reports of gangrene associated with the use of the SGLT2 inhibitor class of medicines, a TGA spokeswoman said.
“TGA is aware of the action taken by the FDA and is investigating to determine whether any regulatory action, including the addition of warning statements, is required in the local context,” the spokeswoman said.
Genital gangrene (also known as Fournier’s gangrene) is caused by a bacteria that enters the body through a tear in the skin, destroying tissue as the infection spreads through the perineum.
Patients needed to be told to seek medical attention immediately if they developed a fever and experienced tenderness, redness, or swelling of the genitals or perineum, the FDA said.
If genital gangrene is suspected, the patient needs immediate treatment with broad-spectrum antibiotics and, if necessary, surgical debridement of dead or damaged tissue.
“Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycaemic control,” the FDA said.
SGLT2 inhibitors improve glycaemic control through enabling excess glucose to be excreted in the urine.
In Australia, the SGLT2 inhibitors currently available are dapagliflozin and empagliflozin, with the brand names Forxiga, Qtern, Xigduo XR, Jardiance, Jardiamet and Glyxambi.