Isotretinoin
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Isotretinoin: Malignant hypertensive renal disease
One-Sentence Summary
This listing conflicts with its known clinical use in severe recalcitrant nodular acne and may be a data-mapping artifact.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Malignant hypertensive renal disease |
| TxGNN Prediction Score | 0.9901 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Isotretinoin is a retinoid. Retinoid signalling has been studied in vascular and renal biology, but this is a hypothesis and not established evidence for treating malignant renovascular hypertension.
A second prediction, malignant hypertensive renal disease, has an identical score (0.9901).
Overall, no supported mechanistic link exists between isotretinoin and malignant renovascular hypertension. The high score should be read as a model output only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
Twenty valid single-ingredient registrations are on record. The five main ones are listed below. None of them has approved indication text on file.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 97044 | Gloret 10mg Tablet | Strip of 10 tablets | Not specified |
| 109591 | Isozit 20mg Soft Gelatin Capsule | Strip of 10 soft gelatin capsules | Not specified |
| 109482 | Isina 20mg Capsule | Strip of 10 capsules | Not specified |
| 241821 | Wontret 20mg Tablet | Strip of 10 tablets | Not specified |
| 200705 | Sotret NF 24mg Capsule | Strip of 10 soft gelatin capsules | Not specified |
All products are oral forms (tablets and capsules).
Safety Considerations
- Contraindications recorded in the knowledge graph (graph relationships, not label text):
- Psychiatric: anxiety disorder, neurotic disorder, dysthymic disorder, psychotic disorder, schizophreniform disorder, schizoaffective disorder, mental disorder
- Liver, kidney and pancreas: liver disease, kidney disease, pancreatitis, gallbladder disease, pyoureter
- Metabolic and bone: diabetes mellitus, diabetic ketoacidosis, potassium deficiency disease, hyperuricemia, osteoporosis, postmenopausal osteoporosis
- Immune, blood and vascular: inflammatory bowel disease, systemic lupus erythematosus (including paediatric), neutropenia, agranulocytosis, hypotensive disorder
- Angioedema (all types): acquired, hereditary, hereditary with C1Inh deficiency, non-histaminic, and RAAS-blocker-induced
- Known safety concerns (from the repurposing assessment): teratogenicity (boxed warning, iPLEDGE REMS), hypertriglyceridaemia and hepatotoxicity. In a kidney-related hypertensive condition, isotretinoin may worsen the dyslipidaemia that is common in kidney disease.
- Drug Interactions: 98 interactions are recorded. The Major-level ones among those listed are:
- Doxycycline
- Minocycline
- Tetracycline
- Vitamin A
Moderate-level interactions include:
- Corticosteroids (betamethasone, budesonide, dexamethasone, hydrocortisone, prednisolone, prednisone, triamcinolone)
- Warfarin and dicoumarol
- Naltrexone
- Ethanol
- Ivacaftor and lumacaftor
- Nitisinone
- Fostamatinib
- Abametapir (topical)
Package insert warnings and contraindications could not be obtained for this report. Please refer to the package insert for label safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has only model-based support (L5), with no clinical trials and no literature. The drug’s known safety profile (teratogenicity, lipid elevation, hepatotoxicity, many interactions) is unfavourable for a severe hypertensive condition.
To proceed, the following is needed:
- Verification of the original indication mapping (isotretinoin’s known use is acne)
- Mechanism of action data (for example from DrugBank) to assess any link between retinoid signalling and renovascular or hypertensive renal disease
- Package insert warnings and contraindications from Indian sources, to allow safety screening
- Preclinical or clinical evidence that retinoids affect malignant renovascular hypertension
- A benefit-risk analysis covering teratogenicity, lipid effects and liver and kidney safety in this patient population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.