Selenium
| Evidence Level: L4 | Predicted Indications: 1 |
Table of Contents
- Selenium
- Pharmacist Assessment Report
- Selenium: From an Unspecified Original Indication to Sclerosing Cholangitis
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Canada Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Selenium: From an Unspecified Original Indication to Sclerosing Cholangitis
One-Sentence Summary
Selenium is an essential trace element supplied in trace-element products marketed in Canada, although no approved indication text is available in the data compiled for this report. The TxGNN model predicts it may be effective for sclerosing cholangitis, but there are currently 0 clinical trials and only 5 loosely related publications, none of which tests selenium as a treatment. This prediction rests on computational modelling alone and should be treated as a hypothesis.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (no approved indication text in the Canadian licence records) |
| Predicted New Indication | Sclerosing cholangitis |
| TxGNN Prediction Score | 0.9904 |
| Evidence Level | L4 |
| Canada Market Status | Marketed (marketed DINs: 5 of 6; cancelled: 1) |
| Number of DINs | 6 (marketed: 5) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, selenium is an essential trace element and a cofactor of glutathione peroxidase and other selenoproteins, which give it antioxidant activity. The data compiled for this report do not state an original approved indication.
Oxidative stress and cholestatic injury are plausibly involved in the pathophysiology of sclerosing cholangitis, so an antioxidant trace element could be mechanistically relevant. This is a plausible hypothesis, not an established link.
The retrieved literature should be read with caution. The papers describe altered hepatic selenium and copper retention in primary sclerosing cholangitis (PSC) as an association or nutritional-status observation. They do not show selenium working as a treatment. No evidence shows that selenium supplementation changes the disease course, cholestasis markers, or outcomes in PSC. The high TxGNN score (0.9904) is a model output only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 9053974 | 1995 | Observational | Scand J Gastroenterol | Trace element metabolism studied in 32 PSC patients; reports hepatic retention of copper and selenium (an association, not a treatment effect) |
| 39601354 | 2025 | Observational | Liver Int | Dietary intake survey in PSC patients; poor fat-soluble vitamin intake and dietary quality compared with Nordic recommendations |
| 29148959 | 2017 | Clinical study (case) | JPEN J Parenter Enteral Nutr | Parenteral nutrition with GGT monitoring and a lipid emulsion in a patient with overlapping PSC and ulcerative colitis; selenium is only part of the nutrition context |
| 17109383 | 2006 | Preclinical | Proteomics | Hepatic proteome changes in mouse models of toxic fibrosis and sclerosing cholangitis; no selenium intervention |
| 18941372 | 2008 | Review | Eur J Cancer Prev | Review of colorectal cancer chemoprevention; only peripherally related to PSC |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 01986007 | MICRO SE | Not specified | Not specified |
| 02536145 | MICRO+ TE PEDIATRIC | Not specified | Not specified |
| 02552787 | MICRO+6 REGULAR | Not specified | Not specified |
| 02507587 | MICRO+6 CONCENTRATE | Not specified | Not specified |
| 02091100 | MICRO PLUS 6 (PEDIATRIC) | Not specified | Not specified |
A sixth license, ADDNUTRIV (DIN 02497697), is also on the market.
Safety Considerations
Drug Interactions (6 interactions found, from a DDInter query):
| Interacting Drug | Severity |
|---|---|
| Dimercaprol | Major |
| Levofloxacin | Moderate |
| Triethylenetetramine | Moderate |
| Deferiprone | Moderate |
| Tolevamer | Moderate |
| Eltrombopag | Moderate |
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high, but it is a computational output only. No clinical trials exist, and the supporting literature describes an association between selenium and PSC rather than a treatment effect. The evidence level is L4, and the Canadian licence records give no approved indication or label safety information.
To proceed, the following is needed:
- Health Canada package insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism of action data (for example from DrugBank) to support a mechanistic link to PSC
- Approved indication, dosage form and route information for the Canadian products
- Targeted literature on selenium supplementation in cholestatic or PSC patients, such as interventional or cohort studies
- A safety plan covering interactions, especially the major interaction with dimercaprol, and selenium toxicity at higher doses
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.