Drug-makers to add AGEP as adverse effect in Patient Information Leaflet of Itraconazole: CDSCO Panel

Acute generalized exanthematous pustulosis (AGEP) is a severe, usually drug-related reaction, characterized by an acute onset of mainly small non-follicular pustules on an erythematous base and spontaneous resolution usually within two weeks.

This came in line with the recommendation of the signal review panel of National Coordinating Centre(NCC) -Pharmacovigilance Programme of India (PvPI), which was placed before the committee.

Itraconazole is an antifungal agent used for the treatment of various fungal infections in immunocompromised and non-immunocompromised patients, such as pulmonary and extrapulmonary blastomycosis, histoplasmosis, and onychomycosis.

Itraconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Itraconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis.

A few brands of Itraconazole include Cipla's Itranox 100 mg capsule, Sun Pharma's Alcros 100mg Capsule, Lupin's Fungeeheal 100mg Capsule, Glenmark's Canditral 100mg Capsule, etc.

At a recent SEC meeting for antimicrobial and antivirals, the recommendation of the signal review panel, PVPI, IPC, was placed before the committee regarding the adverse reaction related to the antifungal agent, Itraconazole.

In view of the above, after detailed deliberation, the committee recommended,

"CDSCO should request the State Drug Controllers to direct the manufacturers to include Itraconazole associated Acute Generalized Exanthematous Pustulosis (AGEP) as adverse effect in the corresponding PIL of the drug."