Prasugrel

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.

Assessment report for Efient (prasugrel) Doc.Ref.: EMEA/117561/2009

"Environmental chemistry, fate and effects data were collected for prasugrel as recommended in the Guideline for environmental risk assessment of medicinal products for human use (CHMP/SWP/4447/00). The Phase I estimate of maximum exposure to all prasugrel residue in surface water predicted an exposure above the 0.01 µg/L and thus, a complete risk assessment (Phase II Tier A) according to the current guideline has been conducted. No likely risk has been identified with regard to aquatic organisms in either ground water or surface water, neither for sediment dwelling organisms."

"A complete environmental risk assessment has been conducted for prasugrel. No likely risk has been identified for aquatic organisms in either ground water or surface water, or for sediment dwelling organisms."

Fass environmental information

Fass environmental information for Efient from Daiichi Sankyo Nordics (downloaded 2021-01-19).

Hazard

Persistence: "Because the calculated DT₅₀ values from the total water-sediment systems were less than one day and because the hydrolysis of prasugrel is rapid (2,29 days or less), prasugrel is considered to be degraded in the environment."

Bioacumulation: "The log K_ow was measured to be 2,27, 3,80, and 5,66 at pH values of 4, 7, and 9, respectively (Study 1982.6226, based on OECD 107). Prasugrel is an ionic compound for which the measured log K_ow increases over the environmental range. The measured log K_ow of prasugrel at pH 7 is less than 4 and, therefore, indicates that prasugrel is not expected to bioaccumulate in the environment. While log K_ow is greater at higher pH values, prasugrel’s rapid degradation to more polar entities as well as its extensive metabolism to more polar metabolites, support the conclusion that prasugrel has low potential for bioaccumulation."

Chronic toxicity: There are data for 3 trophic levels, most sensitive "Fathead minnow (Pimephales promelas) (OECD 210) NOEC 5 d embryos + 28 d larvae (mortality, growth) = 190 μg/L."

Risk

PEC/PNEC is based on sales data in Sweden in year 2016. PEC/PNEC = 0.00001 which gives the risk insignificant.