Daptomycin
Summary
Persistence. Daptomycin is degraded in the environment.
Bioaccumulation. Daptomycin has low potential for bioaccumulation.
Toxicity. Daptomycin has low chronic toxicity.
Risk. The use of daptomycin (sales data Sweden 2021) has been considered to result in insignificant environmental risk.
This summary information comes from fass.se for daptomycin.
For antibiotics in general, it is recommended that these pharmaceuticals are used as restrictively as possible without jeopardise the patient's health.
Detailed information
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.
Assessment report
Assessment report for Cubicin (daptomycin) 12 October 2017, EMA/683418/2017, type II variation.
"An original environmental risk assessment has been submitted during the procedure, with only Phase I testing completed. According to the MAH, the extension of indication will not result in a substantial change in sale. However, the PEC calculation appearing in the original ERA cannot be agreed to. In case of adults, the PECsurface water is 3.6 μg/l; in case of children 0.48 μg/l. Even in case it is assumed that adults are only treated for 14 days per year, the PEC surface water is 0.08 μg/l and thus higher than the action limit of 0.01 μg/l. Therefore, a Phase II ERA is required for Cubicin." No such data have been found on the EMA website (2025-05-13).
Fass environmental information
Fass environmental information for Cubicin from MSD (accessed on 2025-05-13).
Hazard
Persistence: Since half-life < 32 days for total system, daptomycin is degraded in the environment.
Bioaccumulation: Log K < -2 at 7 (OECD 107).
Toxicity: There are data for 3 trophic levels, most sensitive fish NOEC (Pimephales promelas) 5100 microg/L.
Risk
PEC/PNEC is based on sales data in Sweden in year 2021. PEC/PNEC = 0.0000016 which gives the risk insignificant.
Author: Health and Medical Care Administration, Region Stockholm