Ioversol

Evidence Level: L5

Predicted Indications: 9

Ioversol

Pharmacist Assessment Report

Ioversol: From an Iodinated Contrast Agent (No Labelled Indication on File) to Osteoarthritis

One-Sentence Summary

Ioversol is an iodinated contrast agent, but the data compiled for this report contain no approved-indication text for it. The TxGNN model predicts it may be effective for osteoarthritis, but no clinical trials and no publication that studies ioversol itself in this disease support the prediction. The one linked paper studies an embolization procedure with a different agent, so this is essentially a computational prediction.

Quick Overview

Item	Content
Original Indication	Not available (no indication text in the Canadian licence records)
Predicted New Indication	Osteoarthritis
TxGNN Prediction Score	0.9963
Evidence Level	L5
Canada Market Status	Approved but not marketed (approvals on record: 2)
Number of DINs	2 (marketed: 0)
Number of approvals	2 (both single-ingredient products)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Ioversol is an iodinated contrast agent, a class used to enhance imaging rather than to treat disease. It has no known pharmacological anti-osteoarthritis activity.

The only linked publication (PMID 38102013, the LipioJoint-1 trial) studied genicular artery embolization for knee osteoarthritis using an ethiodized oil emulsion (Lipiodol). That paper does not study ioversol as a treatment. Contrast agents such as ioversol may be used incidentally to guide angiography during such procedures, so the link is procedural and indirect.

The high TxGNN score is a computational prediction without a supporting mechanism. It should not be read as evidence of efficacy.

Because no cited study directly examines ioversol in osteoarthritis, the evidence level is L5. The earlier internal label of L4 is not supported.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
38102013	2024	Single-arm clinical trial	Diagnostic and Interventional Imaging	Evaluated safety and efficacy of transient genicular artery embolization using an ethiodized oil emulsion for knee osteoarthritis. Ioversol was not the studied agent.

Canada Market Information

DIN	Product Name	Dosage Form	Approved Indication
01900854	OPTIRAY 320	Not listed	Not listed
02035626	OPTIRAY 320 (ULTRAJECT)	Not listed	Not listed

Both records are single-ingredient products with valid status.

Safety Considerations

Drug Interactions: The interaction query returned 100 records; the main ones are listed below. Most are rated Major.
- Major: metformin, amphotericin B (including lipid complex, cholesteryl sulfate and liposomal forms), mesalazine, balsalazide, olsalazine, sulfasalazine, vancomycin, kanamycin, neomycin, streptomycin and polymyxin B
- Moderate: mannitol
- Unknown severity: atropine, famotidine, acetylsalicylic acid, morphine, omeprazole

Please refer to the package insert for warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction rests on a model score alone. The only linked study used a different agent (ethiodized oil) in an embolization procedure, and ioversol has no known anti-osteoarthritis mechanism.

To proceed, the following is needed:

Health Canada package insert warnings, contraindications and approved indication text, which are currently missing and block safety screening
Mechanism of action data from DrugBank
Any study that directly tests ioversol in osteoarthritis, or a plausible mechanistic rationale
A review of the many Major-level drug interactions before any new use is considered
Disclaimer

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