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.
“This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. USFDA has revised the labels of SGLT 2 inhibitors to include new warnings about the risk to patients,’’ noted the Ministry.
It added that the issue was examined in consultation with Subject Expert Committee (SEC) of CDSCO and information available under the Pharmacovigilance Programme of India (PvPI) has also been obtained.
Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys and nerves. The most common is type-2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or doesn’t make enough insulin. In the past three decades the prevalence of type-2 diabetes has risen dramatically in countries of all income levels, according to the World Health Organisation.
Union Health Minister Dr. Mansukh Mandaviya had stated in Parliament that while the exact number of patients suffering from diabetes in India is not known, however, as per 10th edition of Diabetes Atlas 2021 of International Diabetes Federation (IDF), the estimated number of patients with diabetes between the age group of 20-79 years is 74.2 millions in year 2021 and it is estimated to be increased to 124.8 millions in year 2045.
