Magnesium Hydroxide
| Evidence Level: L3 | Predicted Indications: 6 |
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, but this is essentially its original indication family rather than a true repurposing. Currently there are 0 registered clinical trials and 9 publications for this prediction, mostly old studies of aluminum/magnesium hydroxide combination products.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Peptic ulcer disease, gastroesophageal reflux disease, esophagitis, constipation, dyspepsia (from the knowledge graph; no approved indication text is available in the US license records) |
| Predicted New Indication | Active peptic ulcer disease |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L3 |
| US Market Status | Cancelled only (all licenses cancelled) |
| Number of NDAs | 3 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, magnesium hydroxide is an antacid that neutralizes gastric acid. Reduced acid exposure supports ulcer pain relief and healing.
Peptic ulcer disease is already part of this drug’s original indication family, so the prediction is reasonable but not novel. The supporting literature consists mainly of studies of aluminum hydroxide plus magnesium hydroxide combinations (for example Maalox), including gastric pH studies and comparator trials. Rat studies also suggest a gastroprotective effect involving endogenous prostaglandins.
Evidence is mostly for combination products and is dated. Modern proton pump inhibitor and H. pylori eradication regimens have largely replaced antacids as ulcer therapy.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 3018068 | 1986 | Clinical physiology study | J Clin Gastroenterol | Sodium bicarbonate vs aluminum/magnesium hydroxide (Maalox) on postprandial gastric acid buffering in duodenal ulcer patients |
| 3903784 | 1985 | Controlled clinical trial | Pharmatherapeutica | 30 outpatients with gastric or duodenal ulcer; Al/Mg hydroxide antacid alone vs antacid plus triletide over 8 weeks |
| 4059297 | 1985 | Clinical trial | Pharmatherapeutica | 30 duodenal ulcer outpatients randomized to antacid, triletide, or both for 8 weeks |
| 1526089 | 1992 | RCT | Clin Pharmacol Ther | Nizatidine vs placebo in benign gastric ulcer; the antacid was not the test drug |
| 9305482 | 1997 | Cohort/clinical study | Aliment Pharmacol Ther | Effect of H2 antagonists and antacids on H. pylori gastritis in duodenal ulcer patients; reported an aggravating effect |
| 2228342 | 1990 | Review | Int J Clin Pharmacol Res | Antacids and upper GI mucosal protection, including prostanoid changes with Al/Mg hydroxide in gastric ulcer patients |
| 3660893 | 1987 | Review | Z Gastroenterol | Al/Mg hydroxide antacid mixtures healed gastric and duodenal ulcers better than placebo and comparably to H2 blockers |
| 2595273 | 1989 | Animal study | Scand J Gastroenterol | In rats, an Al/Mg hydroxide antacid dose-dependently prevented gastric lesions |
| 35720246 | 2022 | In vitro study | Med Pharm Rep | Acid-neutralizing capacity of antacids marketed in Morocco |
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| M007 | MILK OF MAGNESIA CHERRY (CVS) | Liquid | Not available (cancelled) |
| 505G(a)(3) | Dulcolax (Chattem, Inc.) | Liquid | Not available (cancelled) |
| M001 | Humco Milk of Magnesia (Humco Holding Group, Inc.) | Suspension | Not available (cancelled) |
Safety Considerations
- Disease contraindications (knowledge graph, not label text): kidney disease and impaired renal function, nephrolithiasis, nephrocalcinosis, liver disease, gallbladder disease, hypercalcemia, hyperparathyroidism, hypophosphatemia and phosphorus metabolism disease, diarrheal disease, intestinal impaction, appendicitis, hemorrhoid, sarcoidosis, and gastric cancer or neoplasm. Several of these relate to magnesium load or phosphate binding.
- Literature safety signals: antacid use can bind phosphate and affect mineral metabolism. One case report describes osteomalacia and hip fracture after long-term magnesium hydroxide use.
- Drug Interactions: 100 interactions were found in total. The one Major interaction is with dolutegravir. Moderate ones include doxycycline, alendronic acid, hydrocortisone, tramadol, acetazolamide, hydrochlorothiazide, amiodarone and amiloride. Minor ones include famotidine, ranitidine and ibuprofen.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction mostly restates the drug’s original indication, and the supporting evidence comes from old, mostly combination-product studies with no registered trials. All US licenses are cancelled, and ulcer treatment has moved to PPIs and H. pylori eradication. The other predicted indications (gastrojejunal ulcer, peptic ulcer perforation, gastroduodenitis, gastric ulcer, stomach disease) rest on weaker, indirect evidence.
To proceed, the following is needed:
- Package insert warnings and contraindications (not yet available for review)
- Mechanism of action data
- Modern controlled studies of magnesium hydroxide alone against current standard therapy
- Clarification of the current US regulatory pathway, since all licenses are cancelled
- A renal function and electrolyte monitoring plan, and a review of the dolutegravir interaction
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.