Comment on “Anaphylactic shock following intravenous ranitidine in rural Nepal: a case report”

Abstract

We reviewed the case report by Shrestha et al. describing ranitidine-induced anaphylactic shock. Although the clinical management of the case is clearly presented, the report appears to have limited novelty and originality, as similar cases have already been extensively documented in the literature, spanning a wide clinical spectrum from mild hypersensitivity to fatal outcomes. Moreover, while ranitidine has been withdrawn in many high-income countries, it remains in use across numerous low- and middle-income countries, including Nepal. We therefore argue that for such a report to make a meaningful scientific contribution, its discussion should more explicitly address regional pharmacovigilance gaps, disparities in drug regulation, and the responsibility of national regulatory authorities regarding the continued availability of this agent.

Dear Editor,

We carefully reviewed the case report by Shrestha et al., recently published in the International Journal of Emergency Medicine [1]. While we commend the authors for their successful clinical management of the patient, we would like to highlight several concerns regarding the article’s scientific novelty.

The authors describe a case of anaphylactic shock that developed within minutes following the intravenous administration of 50 mg ranitidine for dyspeptic complaints at a local clinic, presenting with hypotension, respiratory distress, and signs of systemic hypersensitivity. Although ranitidine-induced anaphylactic reactions are rare, they have been reported in the literature and may occur through both immunological and non-immunological mechanisms. Indeed, anaphylactic reactions associated with ranitidine have long been recognized, and numerous case reports—particularly following intravenous administration—have been published.

Anaphylactic reactions to ranitidine following intravenous administration have been documented since the early 1990s [2], with subsequent reports describing a clinical spectrum ranging from mild hypersensitivity to fatal outcomes [3, 4]. Studies have thoroughly elucidated both immunological and non-immunological mechanisms [5, 6], documented these events even in perioperative settings [7], and extensively analyzed their clinical features, cross-reactivity, and skin testing profiles [8]. In this context, the case presented by Shrestha et al. does not appear to extend beyond this well-characterized clinical picture in terms of presentation, mechanism, or management. Therefore, its originality and scientific novelty seem limited, as it largely duplicates a well-documented adverse reaction thoroughly described in existing literature [2–8].

Given that ranitidine has been withdrawn from the market in many countries following concerns regarding N-nitrosodimethylamine (NDMA) contamination, its relevance to current clinical practice in high-income settings is indeed limited [9]. However, it is important to acknowledge that ranitidine remains in use in numerous low- and middle-income countries (LMICs), including Nepal, where access to alternative agents may be restricted by cost or availability. In this context, adverse drug reaction reports from such settings retain a degree of clinical relevance, particularly in drawing attention to the continued risks associated with the drug’s ongoing use. Nevertheless, for this contribution to be meaningful, the discussion should more explicitly address regional disparities in drug regulation, the gaps in pharmacovigilance systems in LMICs, and the responsibility of national regulatory authorities to reconsider the continued market availability of withdrawn or suspended medications. Regrettably, the original discussion misses the opportunity to engage with these critical systemic dimensions.

We believe that the primary criterion for publishing case reports should emphasize an instructive and novel contribution to the medical literature rather than the mere rarity of an event. In its current form, and without a more robust discussion of regional pharmacovigilance implications, the report’s broader scientific contribution remains limited.

Sincerely,

Author contributions

Both authors contributed substantially to the conception and design of the work. HK drafted the manuscript. AB critically revised the manuscript for important intellectual content. Both authors reviewed and approved the final version of the manuscript and agree to be accountable for all aspects of the work.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethical approval

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Consent for publication

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Competing interests

The authors declare no competing interests.