India’s Central Drugs Standard Control Organisation (CDSCO) has issued a safety alert for teneligliptin, a medication used to manage Type 2 diabetes, directing pharmaceutical companies to include bullous pemphigoid as an adverse drug reaction in the drug’s package inserts and promotional literature. The medication is sold under various brand names, including Tenglyn, Teniva, and Tenepla. The alert follows reviews by the National Coordination Centre of the Pharmacovigilance Programme of India and the Subject Expert Committee. These reviews examined real-world adverse drug reaction reports recorded in national databases, including VigiFlow.
Bullous pemphigoid is a rare autoimmune skin condition characterized by large, fluid-filled blisters that can be painful and intensely itchy. The condition requires medical attention. Patients taking teneligliptin have been advised to remain alert to…