Abstract :
Introduction: Chloramphenicol is a broad-spectrum antibiotic with a well-documented history of efficacy against a variety of bacterial infections. Despite its clinical utility, the use of chloramphenicol has significantly declined due to serious and sometimes fatal adverse effects, most notably aplastic anaemia and gray baby syndrome. This systematic review aims to comprehensively evaluate the current evidence on the clinical pharmacology of chloramphenicol, with a particular focus on its adverse effect profile, risk factors, and mechanisms of toxicity.
Materials and Methods: A systematic search was conducted using PubMed, Scopus, Web of Science, and Cochrane Library databases for studies published between 2000 and 2024. Eligible studies included clinical trials, observational studies, case reports, and pharmacovigilance data that reported on the pharmacokinetics, pharmacodynamics, and adverse effects of chloramphenicol in human subjects. Data were extracted and analysed according to PRISMA guidelines.
Results: A total of 56 studies met the inclusion criteria. Chloramphenicol exhibits excellent tissue penetration and acts by inhibiting bacterial protein synthesis via binding to the 50S ribosomal subunit. However, its metabolism via hepatic glucuronidation and subsequent renal excretion can be impaired in neonates and patients with hepatic dysfunction, increasing the risk of toxicity. The review identified haematological toxicity as the most significant adverse effect, including dose-dependent reversible bone marrow suppression and idiosyncratic aplastic anaemia. Risk factors included prolonged use, high plasma concentrations, and genetic predisposition. Other notable effects included gastrointestinal disturbances, neurotoxicity, and hypersensitivity reactions.
Conclusion: While chloramphenicol remains an effective antimicrobial agent, its use is limited by a narrow therapeutic index and a serious toxicity profile. Clinicians must weigh the benefits against potential risks, particularly in vulnerable populations. Therapeutic drug monitoring and genetic screening may improve safety outcomes. Further research is needed to better understand the mechanisms underlying idiosyncratic toxicities and to identify safer analogues or usage strategies.
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