Mebeverine

Evidence Level: L5 Predicted Indications: 10

Table of Contents

  1. Mebeverine
  2. Mebeverine: From Irritable Bowel Syndrome to Cauda Equina Syndrome
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. Singapore Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## Pharmacist Assessment Report

Mebeverine: From Irritable Bowel Syndrome to Cauda Equina Syndrome

One-Sentence Summary

Mebeverine is an antispasmodic originally used for irritable bowel syndrome, and the knowledge graph also lists Clostridium difficile colitis and neurocirculatory asthenia as original indications. The TxGNN model predicts it may be effective for cauda equina syndrome. Currently there are 0 clinical trials and 0 publications supporting this prediction, so it rests on model output alone.

Quick Overview

Item Content
Original Indication Irritable bowel syndrome (knowledge graph; no approved indication text is listed in the Singapore licences)
Predicted New Indication Cauda equina syndrome
TxGNN Prediction Score 98.01%
Evidence Level L5
Singapore Market Status ✓ Marketed
Number of Registrations 2
Recommended Decision Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Based on known information, mebeverine is a gastrointestinal antispasmodic that acts on gut smooth muscle. Its use in irritable bowel syndrome is established, and mechanistically it may relieve smooth muscle spasm in some settings.

Cauda equina syndrome is a neurological emergency caused by compression of the lumbosacral nerve roots. One plausible but unverified link is neurogenic bowel or bladder dysfunction, where smooth muscle spasm could be a symptom. Mebeverine would not address the underlying nerve injury, so at most it could offer symptom relief.

The score may also reflect proximity in the knowledge graph rather than biological relevance. Other predictions for this drug (such as insomnia, rhinitis and mitral valve prolapse) have no clear mechanistic rationale, which suggests caution about the model's output as a whole. Among the ten predictions, gastroduodenitis (score 81.1%) is the closest to mebeverine's current clinical use, but it also has no clinical support.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

Singapore Market Information

Authorization Number Product Name Dosage Form Approved Indication
SIN09873P MEBETIN TABLET 135 mg Tablet, sugar coated Not listed in the data compiled for this report
SIN07666P DUSPATALIN RETARD CAPSULE 200 mg Capsule Not listed in the data compiled for this report

Both licences are valid single-ingredient products for oral use. Mebetin is made by Sam Chun Dang Pharm Co Ltd. Duspatalin Retard is made by Abbott Biologicals B.V., Mylan Laboratories SAS and Abbott Laboratories GmbH.

Safety Considerations

Please refer to the package insert for safety information. No drug interaction records were found for mebeverine in the data compiled for this report, and no contraindicated diseases were identified from the knowledge graph.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction for cauda equina syndrome is supported only by a model score of 0.98, with no clinical trials or literature. The proposed mechanism is speculative, and mebeverine could at most relieve symptoms without treating the nerve compression. All ten predicted indications are at evidence level L5.

To proceed, the following is needed:

  • Mechanism of action data for mebeverine (for example from DrugBank)
  • Package insert warnings and contraindications from the HSA website, which are needed before any safety screening
  • A literature and trial search specific to mebeverine in neurogenic bowel or bladder dysfunction, and in cauda equina syndrome
  • Clarification of the approved indication wording on the two Singapore licences
  • Assessment of route compatibility and the clinical need, since cauda equina syndrome is a surgical emergency and any role for mebeverine would be adjunctive symptom control

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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