Magnesium Hydroxide
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
Magnesium Hydroxide: From Peptic Ulcer Disease to Active Peptic Ulcer Disease
One-Sentence Summary
Magnesium hydroxide is an antacid originally used for peptic ulcer disease, reflux disease, esophagitis, constipation and dyspepsia. The TxGNN model predicts it may be effective for active peptic ulcer disease. This is essentially an on-label use rather than a novel repurposing signal. Currently there are 0 registered clinical trials and 9 publications supporting this direction, mostly dated studies of aluminium-magnesium hydroxide combination products.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Peptic ulcer disease, gastroesophageal reflux disease, esophagitis, peptic esophagitis, constipation, dyspepsia (from the knowledge graph; the Singapore licences carry no indication text) |
| Predicted New Indication | Active peptic ulcer disease |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L3 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 5 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, magnesium hydroxide is an antacid that neutralises gastric acid. Raising intragastric pH relieves ulcer pain and supports healing.
Peptic ulcer disease is already one of the drug's original indications, so "active peptic ulcer disease" is a closely related, more specific restatement. The high TxGNN score therefore mainly reflects a known indication. Supporting evidence is largely from aluminium-magnesium hydroxide combination antacids studied in the 1980s–1990s, plus a 2022 acid-neutralising capacity evaluation and a rat gastroprotection study suggesting involvement of endogenous prostaglandins.
Other predicted indications are weaker. Gastric ulcer and duodenal ulcer are also close to on-label use (L3). Gastrojejunal ulcer, gastroduodenitis, stomach disease and duodenogastric reflux have only indirect or no supporting evidence. Peptic ulcer perforation, gastroparesis and duodenal obstruction have no plausible antacid mechanism and should be held.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 3903784 | 1985 | Controlled clinical trial | Pharmatherapeutica | 30 patients with active ulcers; triletide plus Al/Mg hydroxide compared with Al/Mg hydroxide alone over 8 weeks |
| 4059297 | 1985 | Randomised clinical evaluation | Pharmatherapeutica | 30 duodenal ulcer outpatients; antacid (Al/Mg hydroxide) vs triletide vs combination for 8 weeks |
| 3018068 | 1986 | Clinical pharmacology comparison | J Clin Gastroenterol | Sodium bicarbonate vs Al/Mg hydroxide on postprandial gastric acid buffering in duodenal ulcer patients |
| 1526089 | 1992 | RCT (antacid only as rescue) | Clin Pharmacol Ther | Nizatidine vs placebo in gastric ulcer healing; the antacid is not the test drug |
| 9305482 | 1997 | Cohort / clinical study | Aliment Pharmacol Ther | H2-receptor antagonists and antacids had an aggravating effect on H. pylori gastritis in duodenal ulcer patients |
| 2228342 | 1990 | Review | Int J Clin Pharmacol Res | Antacids may increase prostaglandin synthesis and protect gastroduodenal mucosa; Al/Mg hydroxide studied in 28 gastric ulcer patients |
| 3660893 | 1987 | Review | Z Gastroenterol | Al/Mg hydroxide mixtures healed gastric and duodenal ulcers, better than placebo and comparable to H2 blockers |
| 2595273 | 1989 | Animal study | Scand J Gastroenterol | Al/Mg hydroxide antacid dose-dependently prevented gastric lesions in rats, similar to a PGE2 analogue |
| 35720246 | 2022 | In vitro product evaluation | Med Pharm Rep | Acid-neutralising capacity of antacids marketed in Morocco |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN06592P | AXCEL EVILINE TABLET | Tablet | Not stated |
| SIN06400P | AXCEL EVILINE FORTE SUSPENSION | Suspension | Not stated |
| SIN03484P | HYDROSIL TABLET | Tablet | Not stated |
| SIN07376P | ACTAL PLUS TABLET | Tablet | Not stated |
| SIN08119P | MACGEL TABLET | Tablet | Not stated |
Safety Considerations
- Contraindications / disease associations (from the knowledge graph, not label text):
- Renal and urinary: kidney disease, impaired renal function, nephrolithiasis, nephrocalcinosis, acute urate nephropathy, pyoureter
- Metabolic: hypercalcemia, hyperparathyroidism, osteitis fibrosa, phosphorus metabolism disease, hypophosphatemia, sarcoidosis
- Gastrointestinal: diarrheal disease (including chronic), appendicitis, intestinal impaction, hemorrhoid
- Hepatobiliary: liver disease, gallbladder disease
- Oncology: gastric cancer and related gastric neoplasms, lytic metastatic bone lesion
- Drug Interactions: 100 interactions were recorded. The one rated Major is dolutegravir. Moderate examples include doxycycline, alendronic acid, hydrocortisone, hydrochlorothiazide, amiodarone, acalabrutinib, abiraterone and tramadol. Minor examples include famotidine, ranitidine and ibuprofen.
- Literature signals: Case and review literature report that heavy or prolonged antacid use can bind phosphate and cause osteomalacia. A case report describes osteomalacia and bilateral hip fracture after long-term magnesium hydroxide use as a laxative.
Please also refer to the package insert for label warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Acid neutralisation is an established mechanism for ulcer pain relief and healing, and active peptic ulcer disease is effectively already an original indication. The evidence is dated, based mostly on combination products, and has no registered trials, so it supports L3 at best. The knowledge graph also flags several renal and metabolic cautions.
To proceed, the following is needed:
- HSA package insert warnings, contraindications and approved indication text (currently missing and blocking safety screening)
- Mechanism of action data from DrugBank
- Contemporary evidence for magnesium hydroxide as a single agent, rather than Al/Mg combinations
- Guardrails for patients with renal impairment, and a review of interactions with dolutegravir and other co-medications that interact with magnesium
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.