This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
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 | - Antibiotic- Indicated for lower & upper respiratory tract infection, UTI, gynaecological infection, skin or soft tissue infection etc.
- Antibiotic- Indicated in the treatment of respiratory tract infections, UTI, ENT soft tissue
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)."
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