Amoxicillin linked to Fixed Drug Eruption: Indian Pharmacopoeia Commission Drug Safety Alert
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of October has revealed that penicillin-like antibiotics Amoxicillin is linked with Adverse Drug Reactions (ADRs) named Fixed Drug Eruption which is a distinctive type of cutaneous drug reaction.
This came after preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Amoxicillin is a penicillin derivative used for the treatment of infections caused by gram-positive bacteria, in particular streptococcal bacteria causing upper respiratory tract infections. Furthermore, Amoxicillin is indicated for the treatment of urinary tract infections, upper respiratory-tract infections, bronchitis, pneumonia, otitis media, dental abscess, osteomyelitis, Lyme diseases in children, endocarditis prophylaxis, post-splenectomy prophylaxis, gynaecological infections, gonorrhoea, helicobacter pylori eradication enteric fever.
Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.
Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin binding proteins. Penicillin bind proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action.
Following the preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database, it is reported that Amoxicillin 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 Drug | Indication | Adverse Drug Reaction |
1. | Amoxicillin | For treatment of urinary tract infections, upper respiratory-tract infections, bronchitis, pneumonia, otitis media, dental abscess, osteomyelitis, Lyme diseases in children, endocarditis prophylaxis, post-splenectomy prophylaxis, gynaecological infections, gonorrhoea, helicobacter pylori eradication enteric fever. | 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)."
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