Ferrous Sulfate Anhydrous

Evidence Level: L5

Predicted Indications: 3

Ferrous Sulfate Anhydrous

Pharmacist Assessment Report

Ferrous Sulfate Anhydrous: Vitamin B12- and folate-independent constitutional megaloblastic anemia

One-Sentence Summary

Ferrous sulfate anhydrous is an oral iron supplement that supplies iron for red blood cell production. The TxGNN model predicts it may be relevant to vitamin B12- and folate-independent constitutional megaloblastic anemia, but no clinical trials and no publications in the data compiled for this report support this direction, so it rests on model prediction alone.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	Vitamin B12- and folate-independent constitutional megaloblastic anemia
TxGNN Prediction Score	0.9978
Evidence Level	L5
Australia Market Status	Listed on the PBS Schedule (2 of 2 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items	2 (valid: 2)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available. Iron is required for erythropoiesis and DNA synthesis, which is the general rationale for using iron salts in anaemias caused by low iron.

The link to the predicted disease is weak. Megaloblastic anaemia that does not depend on vitamin B12 or folate is typically caused by a defect in nucleotide metabolism or another genetic cause, not by a lack of iron. A causal relationship with iron supplementation has therefore not been established. The high score should be treated as a model signal that needs expert review, not as evidence of benefit.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

Australia Market Information

ARTG Number	Product Name	Dosage Form	Approved Indication
ARTG 251F	Not available	Not available	Not available
ARTG 8815Y	Ferro-Liquid	Oral liquid containing 30 mg ferrous sulfate heptahydrate per mL, 250 mL	Not available

Both listed licences are valid single-ingredient products.

Safety Considerations

Please refer to the TGA-approved Product Information (PI) for safety information. Label warnings and contraindications are not available in the data compiled for this report.

Drug interactions: 37 interactions were identified in the interaction screen. Examples of those rated moderate include:

Proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, dexlansoprazole)
Tetracycline-class antibiotics (doxycycline, tetracycline, minocycline)
Levofloxacin
Antacids and mineral products (calcium carbonate, aluminium hydroxide, magaldrate, magnesium oxide)
Pancrelipase, sodium sulfate and triethylenetetramine

Minor interactions include cimetidine, zinc sulfate and zinc acetate.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has no supporting trials or publications (evidence level L5), and iron has no established mechanism for correcting megaloblastic anaemia that is independent of vitamin B12 and folate.

To proceed, the following is needed:

Published or registered studies that directly address this disease
Mechanism of action data for the drug and a plausible mechanistic link to the predicted disease
Review of the TGA-approved Product Information for warnings and contraindications
Expert clinical review to exclude a non-iron cause of the condition before any 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.