Dronedarone

Fass environmental information

Fass environmental information for Multaq (dronedarone) from Sanofi AB (downloaded 2023-10-02).

Hazard

Persistence: "Ready biodegradation: Test showed < 25% degradation in 28 days (OECD 301B). Inherent degradability: Test showed 22.8% degradation in 29 days (OECD 302B). Hydrolysis: Test showed 1.6% degradation in 5 days (OECD 111). Dronedarone fails to pass the criteria for ready and inherent biodegradability which justifies the phrase “Dronedarone is potentially persistent”."

Bioaccumulation: Log P_ow = 4,63 vid pH 7 (OECD 107). "Dronedarone has low potential for bioaccumulation, as indicated by a whole fish steady state total radioactive residue (TRR) BCF of 466 and a steady state dronedarone BCF of 134 at the highest test concentration of 11 µg/L. Normalized to 6% body fat, this results in a whole fish TRR BCF of 730 and a Dronedarone BCF of 210. (OECD 305)"

Chronic toxicity: There are data for 3 trophic levels, lowest NOEC for algae (Pseudokirchneriella subcapitata) 4 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2022. PEC/PNEC = 0.8 which gives the risk low.

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.

Assessment report

Assessment report for Multaq, Procedure No. EMEA/H/C/001043 (2009-12-16)
"With respect to the environmental risk assessment, the following conclusions have been drawn: DRO is neither PBT nor vPvB, risk to the microorganisms in a sewage treatment plants, risk to the aquatic compartment, the groundwater compartment and the terrestrial is considered to be negligible. In order to complete the environmental risk assessment, it has been agreed that further studies, i.e. OECD 307 and OECD 308 will be performed as well as recalculation of the kinetic BCF OECD 305 fish BCF study. It has been agreed that these data will provided as a follow-up measures (FUM1 – 3)." No later information has been found when searching the EMA website 2023-10-02.