Sevelamer
Summary
Persistence. It cannot be excluded that sevelamer is persistent, due to the lack of data.
Bioaccumulation. It cannot be excluded that sevelamer bioaccumulates, due to the lack of data.
Toxicity. It cannot be excluded that sevelamer is toxic, since there is not enough data.
Risk. Risk of environmental impact of sevelamer cannot be excluded, due to the lack of environmental toxicity data.
This summary information comes from Fass. It is voluntary for manufacturers to provide information on environmental impact on fass.se.
Detailed information
Fass environmental information
Fass environmental information for Renagel (sevelamer) from Sanofi AB (downloaded 2023-09-19).
Hazard
Persistence: No data.
Bioaccumulation: No data.
Toxicity: There are data for 3 trophic levels but they refer to loading rates. "Because ecotoxicological test results were based on loading rates and not on the concentration in the test medium that the organisms were exposed to the PNEC could not be calculated."
Risk
Risk of environmental impact of sevelamer cannot be excluded, due to the lack of environmental toxicity data.
It is voluntary for manufacturers to provide information on environmental impact on fass.se.
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 can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.
The PEC 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, not all medicinal products containing the same active substance.
Assessment report
Assessment report for Renvela (sevelamer carbonate), Doc.Ref.: EMEA/214544/2009.
"The applicant has provided an environmental risk assessment (Phase I, Phase II Tier A & B). The use of sevelamer carbonate does not seem to represent a risk to the environment."
Author: Health and Medical Care Administration, Region Stockholm