Vigabatrin
Summary
Persistence. The potential for persistence of vigabatrin cannot be excluded, due to lack of data.
Bioaccumulation. Vigabatrin has low potential for bioaccumulation.
Toxicity. It cannot be excluded that vigabatrin is toxic, due to lack of data.
Risk. Risk of environmental impact of vigabatrin cannot be excluded, since no ecotoxicity data are available.
This summary information comes from fass.se. The same data on bioaccumulation is also included in the assessment report.
Detailed information
Fass environmental information
Fass environmental information for Sabrilex (vigabatrin) from Sanofi AB (retrieved on 2025-10-06).
Hazard
Persistence: No data.
Bioaccumulation: Log Kow = -2.16 at pH 7 (OECD 107).
Toxicity: No data.
Risk
PEC = 0.022 microg/L based on sales data in Sweden in year 2022.
Risk of environmental impact of vigabatrin cannot be excluded, since no ecotoxicity data are available.
General information about assessment reports
Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.
The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, as well as possibly other products from the same company, not all medicinal products containing the same active substance.
Assessment report
Assessment report for Kigabeq (vigabatrin), ORPHELIA Pharma SAS, 26 July 2018, EMA/549064/2018.
The applicant submitted an environmental risk assessment (dated 01 September 2016) for Kigabeq 100 mg/500 mg soluble tablets containing vigabatrin, following relevant guidelines. Market data from 2010–2015 show decreased vigabatrin consumption in Europe. The product will be marketed only in countries where Sabril is already available, with no new indications or dosing changes. Therefore, no increase in total released vigabatrin is expected. Vigabatrin is highly water-soluble with a low log Kow (-2.16), so screening for persistence, bioaccumulation, and toxicity is not required. Phase I and, if applicable, phase II ERA are not justified. The applicant commits to re-evaluate environmental risk if marketing expands to countries where vigabatrin is not currently marketed. Information on the environmental risk assessment for Kigabeq from 2016 has not been found on the EMA website.
Author: Health and Medical Care Administration, Region Stockholm