Drug safety alert: IPC flags adverse reactions linked to Cephalosporin
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of March, has revealed that beta-lactam antimicrobials class of drugs, Cephalosporins are linked with Adverse Drug Reactions (ADRs) named Fixed Drug Eruption.
This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Cephalosporins are beta-lactam antimicrobials used to manage a wide range of infections from Grampositive and Gram-negative bacteria.
Cephalosporins are bactericidal and, like other β-lactam antibiotics, disrupt the synthesis of the peptidoglycan layer forming the bacterial cell wall. The peptidoglycan layer is important for cell wall structural integrity. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by penicillin-binding proteins (PBPs). PBPs bind to the D-Ala-D-Ala at the end of muropeptides (peptidoglycan precursors) to crosslink the peptidoglycan. Beta-lactam antibiotics mimic the D-Ala-D-Ala site, thereby irreversibly inhibiting PBP crosslinking of peptidoglycan.
Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Cephalosporins can lead to Fixed Drug Eruption.
Fixed drug eruption (FDE) is a distinctive type of cutaneous drug reaction that characteristically recurs in the same locations upon reexposure to the offending drug.
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 | Cephalosporin Class | Cephalosporins are beta-lactam antimicrobials used to manage a wide range of infections from Grampositive and Gram-negative bacteria | Fixed Drug Eruption |
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)."
