Teneligliptin alert: CDSCO adds bullous pemphigoid to drug safety warning
CDSCO has alerted patients taking teneligliptin about bullous pemphigoid, a rare autoimmune skin condition, and directed drug companies to update safety information. Diabetologists advised patients not to stop medication without consulting doctors and to report unusual blistering rashes promptly
Hyderabad: India’s top drug safety regulator has issued an alert for patients taking the widely prescribed anti-diabetic drug teneligliptin, sold under popular brand names such as Tenglyn, Teniva and Tenepla, to include the rare skin condition bullous pemphigoid as an adverse drug reaction.
As part of the alert, the Central Drugs Standard Control Organisation (CDSCO) has directed drug companies to update the package inserts and promotional literature for the drug, which is used to manage Type 2 diabetes.
The alert follows reviews by the National Coordination Centre for the Pharmacovigilance Programme of India and the Subject Expert Committee, which tracked real-world adverse drug reaction reports using national databases such as VigiFlow.
Bullous pemphigoid is a rare autoimmune skin condition marked by large, painful and intensely itchy, fluid-filled blisters that require medical attention. Diabetologists have also urged patients to remain vigilant about unexplained rashes, hives or skin irritation when starting or continuing long-term medication.
Pharmacovigilance systems rely heavily on patients and doctors reporting unusual health changes, making public awareness an important first line of defence in ensuring drug safety.
A few weeks ago, CDSCO issued a similar warning for patients taking commonly used painkillers and anti-inflammatory drugs such as aceclofenac and ibuprofen after reviews flagged the risk of a recurrent skin condition called fixed drug eruption.
Similar to the earlier warnings, the new advisory on teneligliptin aims to give doctors and patients greater awareness of rare side effects.
Diabetologists, however, stressed that patients should never stop or alter their diabetes medication without consulting their doctor, as sudden changes could destabilise blood sugar levels. If a family member or acquaintance develops unusual blistering skin rashes while taking a teneligliptin-based medication, they should immediately consult a doctor about any necessary changes to their prescription.
