Drug-makers to add AGEP as adverse effect in Patient Information Leaflet of Itraconazole: CDSCO Panel
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has recommended that CDSCO may request State Drugs Controllers to direct the manufacturers of Itraconazole to include Acute Generalized Exanthematous Pustulosis (AGEP) as adverse effect in the corresponding Patient Information Leaflet (PIL) of the drug.
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.
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