After U.S, India confirms cases of infection from diabetes medication

State drug controllers told to include warning for patients using SGLT2 inhibitors

After the U.S. and Canada, India too has admitted incidence of a rare but serious infection of the genitals and area around the genitals among Type-2 diabetes patients using sodium-glucose cotransporter-2 (SGLT2) inhibitors .

This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene.

As a precautionary measure the Central Drugs Standard Control Organization (CDSCO) has requested all State Drug Controllers to direct the manufacturers of SGLT2 inhibitor class drugs named Canagliflozin, Dapagliflozin, Empagliflozin, under their jurisdiction to include warnings in the package insert and promotional literature of these drugs.

The Health Ministry, responding to a question on the adverse reaction to the anti-diabetes medicine by MP P. Velusamy, submitted the information recently.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors and dipeptidyl peptidase IV (DPP-IV) inhibitors are recommended as preferred add-on oral anti-diabetic drugs (OADs) after metformin among type-2 diabetes mellitus (T2DM) patients with atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), and chronic kidney disease (CKD). They are generally many times costlier than other OADs, note experts.

The Ministry submitted in Parliament that CDSCO was notified about a Health Canada communication to all those authorised to market sodium-glucose co-transporter-2 (SGLT2) inhibitors regarding a summary safety review (SSR) on the potential risk of pancreas inflammation (acute and chronic).

United States Food and Drug Administration (USFDA) in its drug safety communications (DSC) has cautioned about cases of rare but serious infection of the genitals and area around the genitals bring reported with use of SGLT2 inhibitors.