Febuxostat

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 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 Adenuric (febuxostat), Doc Ref : EMEA/258531/2008.

"An environmental risk assessment including Phase I was carried out. The Applicant calculated a Phase I PEC_SURFACEWATER of 0.006 μg L ^-1 using the default values specified in the CHMP/SWP/4447/00 draft guideline. However, the Fpen used by the Applicant was 0.01 % rather than the default of 1 %. The use of an Fpen of 0.01 % was not supported by appropriate references. The correct PEC_SURFACEWATER is 0.6 μg L -1 which is well above 0.01 μg L^-1 and a Phase II assessment was requested by CHMP.

A Phase II investigation according to the Guideline on the environmental Risk Assessment of Medicinal Products for human use (EMEA/CHMP/SWP/4447/00) was performed, as requested in the CHMP LoOI), which included the following tests: Activated sludge respiration inhibition test (OECD 209), Assessment of ready biodegradability by measurement of Carbon Dioxide Evolution (OECD 301B), Activated sludge adsorption isotherm (OPPTS 835.1110), Inhibition of growth to the alga Pseudokirchneriella subcapitata (OECD 210), Fish toxicity testing to Pimephales promelas (OECD 203 and 210) and acute and chronic effects to Daphnia magna (OECD 211). As requested by CHMP the applicant commits to perform a study on aerobic transformation in aquatic sediment systems (OECD 308) for febuxostat to complete the Phase II environmental fate and effect analysis and to prove that febuxostat is unlikely to be a concern for the environment."