Cefoxitin
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Cefoxitin: From Bacterial Infections to Infectious Otitis Media
One-Sentence Summary
Cefoxitin is a cephamycin-class injectable antibiotic that is marketed in the United States. The TxGNN model predicts it may be effective for infectious otitis media, but there are currently 0 registered clinical trials and only 2 publications, a case report and a review. Neither publication tests cefoxitin as a treatment, so this remains a model-only prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not listed in the Evidence Pack (cefoxitin is a cephamycin beta-lactam antibacterial) |
| Predicted New Indication | Infectious otitis media |
| TxGNN Prediction Score | 99.30% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 14 (NDA and ANDA licenses combined) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in DrugBank for this record. From known pharmacology, cefoxitin is a cephamycin beta-lactam that inhibits bacterial cell wall synthesis by binding penicillin-binding proteins (PBPs). It also resists many beta-lactamases. Bacterial otitis media is caused by organisms that a cell-wall-active antibiotic can target, so the prediction is biologically plausible.
The support is much weaker than the score suggests. The two retrieved papers are a Mycobacterium fortuitum case report and an MRSA review. Neither evaluates cefoxitin as a treatment for otitis media. MRSA is intrinsically resistant to cefoxitin, and cefoxitin is mainly used as a laboratory marker of methicillin resistance. The prediction therefore looks like graph-based proximity to other infection indications rather than a demonstrated treatment effect.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 8783722 | 1996 | Case report / case series | Clin Infect Dis | Otitis media and mastoiditis due to M. fortuitum. The isolate showed high-level amikacin resistance. Cefoxitin was not tested as treatment. |
| 33061472 | 2020 | Review | Infect Drug Resist | MRSA epidemiology, virulence and antibiotic resistance. Otitis media is listed as one MRSA-related disease. Cefoxitin efficacy was not evaluated. |
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA065415 | Cefoxitin | Injection, powder, for solution | WG Critical Care, LLC |
| ANDA065415 | Cefoxitin | Injection, powder, for solution | Sagent Pharmaceuticals |
| NDA065214 | Cefoxitin and Dextrose | Injection, solution | B. Braun Medical Inc. |
| ANDA065238 | Cefoxitin | Injection, powder, for solution | Hikma Pharmaceuticals USA Inc. |
| ANDA200938 | Cefoxitin | Injection, powder, for solution | Samson Medical Technologies LLC |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The 99.30% score is not backed by any registered trial or by literature that tests cefoxitin for otitis media. The two papers are indirect, and MRSA is intrinsically cefoxitin-resistant. The evidence level is L4, and the package-insert safety review is still blocking.
To proceed, the following is needed:
- Package insert warnings and contraindications (FDA label), which are currently a blocking data gap
- Detailed mechanism of action data from DrugBank
- Comparative or controlled clinical data on cefoxitin for otitis media, or a targeted literature search for it
- Dosing and route evaluation for the ear indication, since route compatibility has not been assessed (cefoxitin is available only as an injectable)
- Note that other predicted indications for cefoxitin have stronger evidence than otitis media. Gonococcal urethritis has multiple 1979-1983 clinical studies, and urinary tract infection has small registered trials. These may be better candidates for follow-up.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.