Central Drugs Standard Control Organisation (CDSCO) has been reported to world community through World Health Organization that carbamazepine can cause Stevens Johnson’s Syndrome as adverse effect.
The CDSCO and the Signal Review Panel of the Pharmacovigilance Programme of India - Indian Pharmacopoeia (SRP - PvPI - IPC ) have requested that all manufacturers of carbamazepine should include Stevens Johnson’s Syndrome as an adverse reaction in the package inserts and on the official websites.
Carbamazepine is used as an anti convulsant used in patients with epilepsy and in patients with trigeminal neuralgia. In India, there are 122 reports of life threatening or fatal skin reactions (Stevens Johnson's Syndrome, Toxic Epidermal Necrolysis) that may have been caused by the use of carbamazepine formulations.
Although Stevens Johnson's Syndrome is a known adverse effect of carbamazepine and is already included in some package inserts, the Subject Expert Committee (SEC) have recommended that all manufacturers should include the same information on this adverse effect.
The CDSCO/PvPI have decided that it was necessary to revise the package insert to include screening of HLA-B 1502 prior to initiating the carbamazepine treatment, as HLA-B 1502 is a known factor for carbamazepine - induced Stevens Johnson’s Syndrome.
