Bromocriptine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Bromocriptine
- Pharmacist Assessment Report
- Bromocriptine: From Parkinson Disease and Hyperprolactinemia to Congenital Disorder of Glycosylation with Defective Fucosylation
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Canada Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Bromocriptine: From Parkinson Disease and Hyperprolactinemia to Congenital Disorder of Glycosylation with Defective Fucosylation
One-Sentence Summary
Bromocriptine is a dopamine agonist originally used for Parkinson disease, hyperprolactinemia, prolactin-producing pituitary tumours, and acromegaly. The TxGNN model predicts it may be effective for congenital disorder of glycosylation with defective fucosylation, but this is a model prediction only, with 0 clinical trials and 0 publications supporting it. Among the other top-10 predictions, schizophrenia (1 trial, many general publications) and retinal dystrophy (2 publications) have somewhat more supporting material.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Parkinson disease, hyperprolactinemia, prolactin-producing pituitary tumour, acromegaly (the Canadian licence records contain no indication text) |
| Predicted New Indication | Congenital disorder of glycosylation with defective fucosylation |
| TxGNN Prediction Score | 0.9983 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 2 of 2) |
| Number of DINs | 2 (marketed: 2) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Bromocriptine is generally known as a dopamine D2 receptor agonist. This explains its use in Parkinson disease and in lowering prolactin and growth hormone in pituitary disorders.
The data compiled for this report identify no mechanistic link between dopamine agonism and fucosylation pathways. The high score (0.9983) reflects a prediction from the TxGNN model (deep learning), not biological or clinical support. The prediction should be regarded as a hypothesis only.
Other predictions among the top 10 have loose biological rationales:
- Retinal dystrophy (rank 3): Retinal dopamine signalling is plausible. A 1991 case series used cyclosporin A plus bromocriptine in Goldmann-Favre syndrome. A 2024 preclinical study tested a combination of tamsulosin, metoprolol and bromocriptine in retinopathy models.
- Myopia (X-linked, syndromic) (ranks 5, 7, 10): Retinal dopamine modulates eye growth, but no evidence exists for bromocriptine in these inherited forms.
- Schizophrenia (rank 9): Dopamine is central to the disease, but a case report describes bromocriptine-induced psychosis, so the direction of effect is a concern. The only registered trial looks at metabolic comorbidity (prediabetes), not core psychiatric symptoms.
Clinical Trial Evidence
Currently no related clinical trials are registered for the top-ranked prediction.
For reference, the only trial found among the top-10 predictions is for schizophrenia (rank 9):
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03575000 | Phase 4 | Not yet recruiting | 15 | Open-label, flexible-dose adjunctive bromocriptine for antipsychotic-associated impaired glucose tolerance in schizophrenia with prediabetes. It is a small, uncontrolled safety and tolerability pilot and provides no efficacy data. |
Literature Evidence
Currently no related literature is available for the top-ranked prediction.
For reference, the most relevant publications among the other top-10 predictions:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39009597 | 2024 | Preclinical study | Nature Communications | Combination of tamsulosin, metoprolol and bromocriptine showed mutation-agnostic efficacy in preclinical retinopathy models (retinal dystrophy, rank 3). |
| 1753674 | 1991 | Case series | Klin Monbl Augenheilkd | Cyclosporin A plus bromocriptine in Goldmann-Favre syndrome (retinal dystrophy, rank 3). |
| 8120934 | 1993 | Case report | J Natl Med Assoc | Schizophrenia developed 4 days after starting low-dose bromocriptine and resolved after discontinuation (safety signal, rank 9). |
| 6574535 | 1983 | Clinical study | Psychiatry Res | Ten chronic schizophrenic patients received escalating bromocriptine doses, with symptoms, sleep and prolactin response assessed (rank 9). |
| 39265262 | 2024 | Systematic review | Schizophr Res | Insulin resistance as a modifiable pathway to cognitive dysfunction in schizophrenia (rank 9, indirect). |
| 30805732 | 2019 | Review | J Neural Transm | Overview of classical dopamine agonists including bromocriptine (rank 9, general pharmacology). |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02230454 | BROMOCRIPTINE | Not available | Not available |
| 02087324 | BROMOCRIPTINE | Not available | Not available |
Both authorisations are single-ingredient products with valid status.
Safety Considerations
Package insert warnings and contraindications were not available in the data compiled for this report. Please refer to the package insert for safety information.
Disease-level contraindication signals (from the knowledge graph, not label text): hypertensive disorders, liver disease, gallbladder disease, coronary artery disease, stroke and cerebrovascular disorders, cerebral infarction, and pre-eclampsia (mild, severe, HELLP syndrome).
Drug Interactions: 87 interactions were recorded. Examples:
- Major: isometheptene, lorcaserin
- Moderate: clarithromycin, metoclopramide, morphine, promethazine, lansoprazole, dronabinol, nabilone, ethanol, deferasirox, ioflupane I-123, fostamatinib
Additional signal: a case report links bromocriptine to new-onset psychosis, which is relevant to any psychiatric repurposing.
Conclusion and Next Steps
Decision: Hold
Rationale: The top-ranked prediction rests on model output alone (L5), with no trials, no literature and no plausible mechanistic link. The safety review cannot proceed because label warnings and contraindications are missing.
To proceed, the following is needed:
- Health Canada package insert warnings and contraindications (blocking gap)
- Mechanism of action data from DrugBank
- A mechanistic rationale linking dopamine agonism to fucosylation defects, or reprioritisation toward better-supported candidates (retinal dystrophy, or schizophrenia with metabolic comorbidity after a psychosis-risk assessment)
- Indication, dosage form and manufacturer details for the two Canadian DINs
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.