SGLT-2 inhibitors to carry safety alerts

September 8, 2019 0 By FM

India’s drug regulator has called for a compulsory warning label on sodium-glucose co-transporter-2 or SGLT2 inhibitor class of anti-diabetes drugs.

The US FDA and Health Canada had issued alerts regarding the safety SGLT-2 inhibitors, such as canagliflozin (Invokana), dapagliflozin (Forxiga) and empagliflozin (Jardiance), as they are suspected of causing serious genital infections.

The Pharmacovigilance Programme of India (PvPI), which monitors adverse drug reactions, has provided some individual case reports to the Central Drugs Standard Control Organisation (CDSCO), reports said.

On the basis of the safety updates, the CDSCO has asked all state drug controllers to direct manufacturers of SGLT-2 inhibitors to carry a warning in the package insert and promotional literature.

SGLT2 inhibitors, which work by preventing glucose re-uptake, have also been implicated in the spread of a rare and fulminant infection called necrotizing fasciitis of the perineum and genital region, also known as Fournier’s gangrene.

Fournier’s gangrene was spotted by the US FDA in 12 patients taking SGLT2 inhibitors between the years 2013 and 2018. The polymicrobial infection developed within several months of patients starting SGLT2 therapy. All patients required surgery and one death was reported.

Health Canada published a summary safety review of SGLT inhibitors in July 2018, observing the potential risk of inflammation of the pancreas.

SGLT2 inhibitors were approved by the US FDA in 2013 for use with diet changes and exercise to lower blood sugar in adults with type 2 diabetes.