Drug safety alert: IPC flags adverse reactions linked to Cefuroxime
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of April, has revealed that a cephalosporin antibiotic Cefuroxime is linked with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome.
This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Cefuroxime, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefuroxime interferes with an autolysin inhibitor.
Cefuroxime is indicated for lower & upper respiratory tract infection, UTI, gynaecological infection, skin or soft tissue infection etc. Further, the drug is indicated in the treatment of respiratory tract infections, UTI, ENT soft tissue infections etc.
Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Cefuroxime can lead to Adverse Drug Reaction named Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a severe adverse drug reaction presenting with rash, fever, lymphadenopathy, and single or multiple organ involvement.
Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs as given below:
Sl. No | Suspected Drugs | Indication | Adverse Drug Reaction |
1 | Cefuroxime |
infections etc. | Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) |
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 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)."
