Salicylamide
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
Salicylamide: From Analgesic/Antipyretic Use to Pharyngitis
One-Sentence Summary
Salicylamide is a salicylate-type analgesic and antipyretic. The SAHPRA records in this Evidence Pack do not state an approved indication. The TxGNN model predicts it may be useful for pharyngitis (sore throat), which would be symptomatic relief rather than disease modification. Support is thin: no registered clinical trials and 3 old publications (1953-1969), all uncontrolled or not clearly about salicylamide.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in SAHPRA licence records |
| Predicted New Indication | Pharyngitis |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L3 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 4 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available (the DrugBank record has no MOA and no original indication). Based on known information, salicylamide is a salicylate analgesic/antipyretic. Its pain- and fever-relieving effects are plausibly relevant to the symptoms of a sore throat.
The link is therefore symptomatic. Sore throat is a common reason to use simple analgesics and antipyretics, which is why the prediction is credible on its face. It is not confirmed by mechanism data or by controlled evidence.
Clinical Trial Evidence
Currently no related clinical trials registered (ClinicalTrials.gov, ICTRP, SANCTR or PACTR entries were not found in the Evidence Pack).
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 14126993 | 1963 | Clinical experience report | Kinderarztliche Praxis | Experience with a new antipyretic/analgesic in rectal capsule form (paediatric journal). No abstract available. |
| 13060598 | 1953 | Uncontrolled clinical study | Gazzetta medica italiana | Treatment of catarrhal tonsillitis in infants with salicylamide plus sodium p-aminobenzoate. Design inferred from title only. |
| 5354503 | 1969 | Double-blind study | Minerva medica | Compared two bismuth preparations in pharyngo-tonsillitis. Salicylamide does not appear to be the test agent, so relevance is doubtful. |
None of these papers has an abstract or gives usable efficacy data, and all are decades old.
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| G1221 (ACT 101) | Flutex | Capsule | Not stated in record |
| B851 (ACT 101) | Flutex junior cold & flu-alcohol free | Syrup | Not stated in record |
| C759 (OM) | Histamed co | Capsule | Not stated in record |
| C770 (ACT 101/1965) | Ilvico | Tablet | Not stated in record |
The product names suggest cold and flu preparations, but the record gives no indication text, so this is not confirmed. Essential Medicines List status could not be determined from the Evidence Pack.
Safety Considerations
- Drug Interactions: No interaction records were found in the database query.
- Signals in the retrieved literature (from papers found for other predicted indications):
- Overdose toxicity has been reported for salicylamide (PMID 8864802).
- Drug-induced haemolytic anaemia with agranulocytosis occurred in a patient taking a cold preparation containing salicylamide, acetaminophen, caffeine and promethazine, together with an antibiotic (PMID 8952318).
- Antipyretic analgesics can cause hypersensitivity reactions in allergic patients, including those with aspirin-induced asthma (PMID 6606363).
Please refer to the SAHPRA-approved Professional Information (PI) for full warnings and contraindications, which were not available in this Evidence Pack. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: The pharyngitis prediction is plausible as symptom relief, but the evidence is limited to three old, uncontrolled or off-target reports and no registered trials. The SAHPRA safety information is a blocking data gap.
To proceed, the following is needed:
- SAHPRA package insert warnings and contraindications (blocking)
- Approved indication text for the four SAHPRA registrations, and the active ingredients of each product
- Mechanism of action data from DrugBank
- A structured review of current evidence comparing salicylamide with standard sore-throat analgesics, ideally from controlled trials
- Assessment of the haemolytic anaemia, agranulocytosis and overdose signals before any further step
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.