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Approved Formulary
REMS FDA Documents
Search results for:
vigabatrin
vigabatrin
- Restricted Medications Non-Formulary / Not-stocked
- REMS FDA Documents
Brand names: Sabril
No brands, forms, or strengths have been added for this generic.
Display Anticonvulsants, Miscellaneous Class:
281292
Medication comments:
| Per policy, these hazardous drugs have special waste requirements. | |
|---|---|
| Generic (Brand) | Waste Requirements |
| vigabatrin (Sabril) | Hazardous Waste ⇒ BLACK BUCKET |
| USP <800> Hazardous Drugs | ||||||
|---|---|---|---|---|---|---|
| Per Policy, these drugs have special handling requirements (any drug with an "AOR" is exempt from these requirements under normal circumstances). | ||||||
| generic (Brand) Route | Relative Risk Level | AOR? | NIOSH 2024 Table | MSHI?↑ | Warnings | |
| vigabatrin (Sabril) PO | Low | N/A | 2B↑ | |||
| NIOSH Supplemental information (2016): Malformations seen in laboratory studies below the MRHD FDA Pregancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks; | ||||||
| 2023 American Geriatrics Society Beers Criteria® for potentially inappropriate medication use in older adults. | |
|---|---|
| Medication: | vigabatrin (Sabril) |
| Criteria 2: Potentially inappropriate medication use in older adults due to drug–disease or drug–syndrome interactions that may exacerbate the disease or syndrome. (Table 3) | |
| Drug(s) ⇆ disease or syndrome | antiepileptics ⇄ History of falls or fractures |
| Rationale | May cause ataxia, impaired psychomotor function, syncope, or additional falls. If one of the drugs must be used, consider reducing the use of other CNS-active medications that increase the risk of falls and fractures. (i.e., anticholinergics, selected antidepressants, antiepileptics, antipsychotics, sedative/hypnotics including benzodiazepines and, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids) and implement other strategies to reduce fall risk. |
| Recommendation | Avoid except for seizures and mood disorders. |
| Quality of evidence: High, Strength of Recommendation: Strong | |
| Criteria 4: Potentially clinically important drug-drug interactions that should be avoided in older adults. (Table 5) | |
| Interacting drug(s) or class(es) | antiepileptics (including gabapentinoids) ⇄ CNS-active agents |
| Risk Rationale | Increased risk of falls and of fracture with the concurrent use of ≥3 CNS-active agents (antiepileptics including gabapentinoids, antidepressants, antipsychotics, benzodiazepines, Nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids, and skeletal muscle relaxants). |
| Recommendation | Avoid concurrent use of ≥3 CNS-active drugs Click for list; minimize the number of CNS-active drugs. |
| Quality of evidence: High, Strength of Recommendation: Strong | |
Last updated: Sep. 19, 2025
- Hazard.Drug Handling(USP 800) USP<800> Hazardous Drug
- Hazardous Waste BLACK BUCKET
- Black Box Warnings Permanent Vision Loss
- Look-Alike/Sound-Alike vigabatrin confused with dabigatran