Docusate
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Docusate: Surfactant stool softener → Plummer-Vinson syndrome
One-Sentence Summary
Docusate is a surfactant-type stool softener marketed in Canada in many single-ingredient products. The TxGNN model predicts it may be relevant to Plummer-Vinson syndrome, but this is a model prediction only: 0 clinical trials and 0 publications were found to support it.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Plummer-Vinson syndrome |
| TxGNN Prediction Score | 0.9918 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs on record: at least 17; dormant: 1; cancelled: 2) |
| Number of DINs | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data for docusate are not available in the data compiled for this report. Docusate is generally understood as a surfactant stool softener, and it has no known effect on iron status.
Plummer-Vinson syndrome is characterised by iron deficiency anemia, dysphagia and oesophageal webs. The model’s high score most likely reflects shared anemia-related connections rather than a biological mechanism. Docusate does not treat iron deficiency, dysphagia or oesophageal webs, and the standard of care (iron replacement, with endoscopic dilation of webs when needed) is unrelated to docusate’s pharmacology. No plausible mechanistic rationale can be established from the available data.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Canada Market Information
At least 20 valid single-ingredient licences are recorded, and the list may be partial. Examples of products:
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02530538 | NRA-DOCUSATE SODIUM | Not recorded | Not recorded |
| 01994344 | SOFLAX CAPSULES 100MG | Not recorded | Not recorded |
| 02484226 | COLACE CLEAR | Not recorded | Not recorded |
| 02526492 | ENEMEEZ | Not recorded | Not recorded |
| 00870226 | RATIO-DOCUSATE SODIUM | Not recorded | Not recorded |
Safety Considerations
- Drug Interactions (4 recorded):
- Lactulose: Moderate
- Mineral oil: Moderate
- Phenolphthalein: Moderate
- Linaclotide: Minor
Please refer to the package insert for other safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score. No trials or publications study docusate in Plummer-Vinson syndrome, and no mechanistic link is apparent, so the evidence level is L5.
To proceed, the following is needed:
- Mechanism-of-action data for docusate
- Package insert warnings and contraindications from Health Canada
- Any preclinical or clinical study directly addressing docusate in Plummer-Vinson syndrome
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.