Drug makers to add drug reaction Acute Generalized Exanthematous Pustulosis in package insert of Cloxacillin: 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 Cloxacillin to include drug associated Acute Generalized Exanthematous Pustulosis (AGEP) in the package insert of the drug.
This came in line with the recommendation of the signal review panel, Pharmacovigilance Programme of India (PvPI), and the Indian Pharmacopoeia Commission (IPC), which was placed before the committee.
Cloxacillin is an antibiotic agent used for the treatment of beta-hemolytic streptococcal and pneumococcal infections as well as staphylococcal infections.
Cloxacillin inhibits the third and last stage of bacterial cell wall synthesis, by binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cloxacillin interferes with an autolysin inhibitor.
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.
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 drug Cloxacillin.
In view of the above, after detailed deliberation, the committee recommended,
"CDSCO may request State Drugs Controllers to direct the manufacturers of the drug to incorporate drug associated Acute Generalized Exanthematous Pustulosis (AGEP) in the package insert of the drug."
