Magnesium Sulfate
| Evidence Level: L3 | Predicted Indications: 8 |
Table of Contents
Magnesium Sulfate: Thrombotic disease
One-Sentence Summary
Magnesium sulfate is an injectable magnesium product that is marketed in Canada under several licences. The TxGNN model predicts it may be effective for thrombotic disease. Support is limited to 1 Phase 3 trial (status unknown, no results), a small nonrandomized pilot study, and several older preclinical studies, so the evidence level is L3.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Thrombotic disease |
| TxGNN Prediction Score | 0.9990 |
| Evidence Level | L3 |
| Canada Market Status | Marketed (marketed DINs: 8 of 8) |
| Number of DINs | 8 (marketed: 8) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data for magnesium sulfate are not available in the data compiled for this report. The mechanistic reasoning below therefore rests on published preclinical work rather than on an established label mechanism.
In animal models, magnesium sulfate reduced platelet deposition and thrombus formation after arterial injury. In a rat carotid thrombosis model, infusion prevented or delayed clot formation and also impaired coagulation in vivo. The likely explanations are calcium antagonism and effects on platelet aggregation. These are plausible but unproven in humans.
Human data are sparse. A small nonrandomized pilot study gave magnesium to patients undergoing coronary stent implantation, a setting where stent thrombosis is a concern. The only registered randomized trial studies thrombotic thrombocytopenic purpura (TTP), a specific thrombotic microangiopathy, so it does not cover thrombotic disease in general. That trial’s status is unknown and no results are available.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03237819 | Phase 3 | Unknown | 74 | Multicentre randomized trial of magnesium sulfate in TTP patients in intensive care (2018–2021). No results are available. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 14506544 | 2003 | Prospective, nonrandomized, open-label pilot | J Cardiovasc Pharmacol Ther | Tested the feasibility of giving magnesium to patients undergoing nonacute coronary stenting, after animal data suggested it inhibits acute stent thrombosis. |
| 3441141 | 1987 | Preclinical | Magnesium | Magnesium sulfate reduced thrombus formation at sites of arterial constriction and endothelial damage in dogs and rabbits. |
| 11816720 | 2001 | Preclinical | Thromb Haemost | In rats, magnesium infusion prevented or delayed FeCl3-induced carotid thrombus formation and impaired coagulation in vivo. |
| 7368083 | 1980 | Preclinical | Surgery | Magnesium sulfate reduced platelet and erythrocyte deposition after temporary arterial occlusion in rabbits. |
| 14168822 | 1964 | Clinical report | Practitioner | Historical report on parenteral magnesium sulphate in arterial disease. No abstract is available. |
| 8024163 | 1994 | Clinical study | Angiology | Magnesium sulfate infusion in 12 women with primary Raynaud’s phenomenon and 12 controls. Plasma noradrenaline and neuropeptide Y were measured, a vascular rather than thrombotic outcome. |
Canada Market Information
Magnesium sulfate is marketed in Canada, and all eight licences in the local records are valid products. Approved-indication text and dosage forms are not recorded in the local data. Five representative licences are listed below.
| DIN | Product Name |
|---|---|
| 02139499 | Magnesium Sulfate Injection, USP |
| 02513161 | Magnesium Sulfate Injection, BP 49.3% |
| 02542153 | Magnesium Sulfate in Water for Injection |
| 00392618 | Magnesium Sulfate Injection USP |
Safety Considerations
- Drug Interactions: 92 potential interactions are recorded. Major-level interactions include dolutegravir, amikacin and bictegravir. Moderate-level interactions include nifedipine, amlodipine, doxycycline, tetracycline, ciprofloxacin, cisatracurium, several corticosteroids, and bisphosphonates such as alendronic acid and risedronic acid.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The only randomized trial addresses TTP specifically, and its status is unknown with no results. The remaining support is one small nonrandomized pilot study and older animal studies. This supports a research question, not a clinical recommendation.
To proceed, the following is needed:
- Results or an updated status for NCT03237819
- Randomized human data in a defined thrombotic condition, such as stent thrombosis, with clinical thrombotic endpoints
- Mechanism of action data for magnesium sulfate, to support the proposed antithrombotic effect
- Review of the package insert warnings and contraindications, including the 92 recorded drug interactions, before any design of a new-use study
- Assessment of bleeding risk when magnesium is combined with anticoagulants or antiplatelet agents
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.