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.