Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To Metronidazole
New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of August, has revealed that the popular antibiotic Metronidazole is linked with adverse drug reactions (ADRs) named Fixed Drug Eruption (FDE).
In connection with the above, the Indian Pharmacopoeia Commission (IPC) has cautioned healthcare professionals to diligently monitor the potential occurrence of adverse drug reactions (ADRs) when administering metronidazole.
This came after a preliminary analysis of adverse drug reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.
Metronidazole is a commonly used antibiotic, belonging to the nitroimidazole class of antibiotics. It is frequently used to treat gastrointestinal infections as well as trichomoniasis giardiasis, and amebiasis, which are parasitic infections.
After administration, metronidazole enters cells by passive diffusion. Following this, ferredoxin or flavodoxin reduce its nitro group to nitro radicals. The redox potential of the electron transport portions of anaerobic or microaerophilic microorganisms renders metronidazole selective to these organisms, which cause nitro group reduction, leading to the production of toxic metabolites. These include N-(2-hydroxyethyl) oxamic acid and acetamide, which may damage the DNA of replicating organisms.
The alert noted that metronidazole is indicated for the treatment of amoebiasis, urogenital trichomoniasis and giardiasis.
Following the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database, it is reported that metronidazole can lead to Fixed Drug Eruption (FDE).
A fixed-drug eruption (FDE) is a unique cutaneous adverse drug effect in the form of recurrent lesions at the same site after re-exposure to the offending agent.
Now, as per the issued drug safety alert, the following suspected drug is associated with the ADR, as given below:
Sr. No | Suspected Drug | Indication | Adverse Drug Reaction |
1 | Metronidazole | For the treatment of Amoebiasis, urogenital trichomoniasis & giardiasis | Fixed Drug Eruption (FDE) |
In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised healthcare professionals, patients, and consumers to closely monitor the possibility of the above ADRs associated with the use of the above-suspected drugs.
Further, the safety alert added, "If such reaction is encountered, please report to the NCC-PvPI, IPC by filling out 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).
To view the official notice, click the link below:
