Drug Safety Alert: Indian Pharmacopoeia Commission Flags Adverse Reactions Linked To Teneligliptin

This came after a preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

Teneligliptin is a recently developed oral dipeptidyl peptidase 4 inhibitor indicated for the management of type 2 diabetes mellitus (T2DM) in adults along with diet and exercise. The mechanism of Teneligliptin is to increase incretin levels (GLP-1 and GIP), which inhibit glucagon release, which in turn increases insulin secretion, decreases gastric emptying, and decreases blood glucose levels.

Teneligliptin inhibits the action of DPP-4 enzymes and slows down the rapid degradation of incretins. It also increases insulin synthesis by the pancreas and decreases glucagon levels which are a counter-hormone of insulin, thereby further decreasing blood sugar levels.

In accordance with the drug safety alert, Teneligliptin which is indicated for the treatment of Type-2 Diabetes Mellitus as a monotherapy adjunct to diet and exercise, can cause adverse drug reactions (ADRs) named Bullous Pemphigoid.

Bullous pemphigoid is a rare skin condition that causes large, fluid-filled blisters. They develop on areas of skin that often flex such as the lower abdomen, upper thighs, or armpits. Bullous pemphigoid is most common in older adults.

Bullous pemphigoid occurs when the immune system attacks a thin layer of tissue below your outer layer of skin. The reason for this abnormal immune response is unknown, although it sometimes can be triggered by taking certain medications.

Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs as given below:

In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised Healthcare Professionals, Patients/Consumers to closely monitor the possibility of the above ADRs associated with the use of the above-suspected drugs.

Further, the safety alert added, "If such reaction is encountered, please report to the NCC-PvPI, IPC by filling of Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPIHelpline No. 1800-180-3024 (Toll Free)."

Teneligliptin is sold under a variety of brand names in India, including Zydus Cadila’s TENGLYN, Mankind Pharma’s DYNAGLIPT, Glenmark Pharmaceutical’s ZITEN and ZITA PLUS, Macleods Pharmaceutical’s TENLIMAC, Intas Pharmaceutical’s TENIVA, Torrent Pharmaceutical’s TENEZA and Alembic Pharmaceuticals ETERNEX-T, Aristo Pharmaceutical’s MEGAGLIPTIN, Cadila Pharmaceutical’s TENALI, Wockhardt’s INOGLA