Ulipristal acetate
Summary
Persistence. Ulipristal acetate is not considered to be readily biodegradable (theoretical assessment).
Bioaccumulation. It cannot be excluded that ulipristal acetate bioaccumulates, due to the lack of data.
Toxicity. It cannot be excluded that ulipristal acetate is toxic, due to the lack of data.
Risk. Emergency contraceptive. Here, the Wise list (the formulary for Region Stockholm, Sweden ed. note) recommends ulipristal acetate as the first choice and levonorgestrel as a second choice. From an environmental risk perspective, ulipristal acetate is a better alternative than levonorgestrel.
This summary information on bioaccumulation and risk comes from the report from Goodpoint. Environmental information is missing on fass.se for ulipristal acetate (2025-04-15).
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). The environmental aspect is not considered in the benefit/risk assessments of human medicines. If new data become available after approval that requires an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the medicines authority.
Assessment report
Assessment report for Ellaone (ulipristal acetate), Laboratoire HRA Pharma, Doc.Ref.: EMEA/261787/2009.
"A Phase I ERA based on the CHMP Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00) adopted by CHMP on 01 June 2006 was provided. The Applicant concluded that the calculated concentration for PECSurface water is less than the 0.01 μg/L threshold value given in the CHMP guideline, and that the release into the environment of ulipristal acetate following the prescribed use of Ellaone is unlikely to represent a risk for the environment. This was not accepted by CHMP because ulipristal acetate is a selective progesterone receptor modulator with the potential to affect the reproductive outcome in many species, making the action limit of 0.01 μg/L potentially not applicable. A phase II environmental risk assessment was requested, which the applicant has committed to perform. A tailored risk assessment strategy should be followed that addresses the specific mechanism of action." No such information has been found on the EMA website (2025-04-15).
Report Goodpoint 2024
The report from Goodpoint 2024 aims to present an overall, comparative assessment for the treatment options recommended for all indications under the therapeutic area of gynecology and obstetrics in the 2024 Wise list (the formulary for Region Stockholm, Sweden) containing either estrogens or progestogens + estetrol. The risk assessment does not aim to assess absolute or quantitative risk (which, for example, strongly depends on dilution in different recipients) but is primarily of a comparative nature, i.e., a ranking of the risk between different treatment options. For more information see the report.
Author: Health and Medical Care Administration, Region Stockholm