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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; | ||||||
Last updated: Jun. 11, 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