Formoterol

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.

Below are some recent assessment reports on formoterol. There are more assessment reports on the EMA website about formoterol with similar information.

Assessment report for DuoResp Spiromax (budesonide, formoterol) 22 April 2021, EMA/CHMP/310290/202

"In accordance with the Guideline on the Environmental Risk Assessment of Medicinal Products for Human use (EMEA/CHMP/SWP/4447/00 corr 2), a justification for the absence of an environmental risk assessment (ERA) has been provided. The applicant states that the proposed budesonide/formoterol Spiromax 80/4.5, 160/4.5, 320/9 µg per dose, inhalation powder products would replace the currently marketed medicinal products and hence the exposure of the environment to budesonide and formoterol is not likely to increase. Therefore, the absence of ERA is considered acceptable."

Assessment report for Trixeo Aerosphere (formoterol, glycopyrronium bromide, budesonide), 15 October 2020, EMA/582495/2020

Hazard

Persistence: No data.

Bioaccumulation enligt OECD107:
log K_ow
-0.837 at pH 5
0.070 at pH 7
0.895 at pH 9.

Toxicity: No data.

Risk

PEC _{surfacewater, default or refined} (e.g. prevalence, literature) 0.000096 microg/L. Conklusion: > 0.01 threshold (N).

"As a result of the above considerations, the available data do not allow to conclude definitively on the potential risk of BGF MDI (abbreviation for budesonide, glycopyrronium bromide, formoterol and Metered Dose Inhaler ed. note) to the environment.Toxicity studies for algal growth and Daphnia growth and reproduction have been completed, however, a fish full life-cycle test is outstanding to address the potential for chronic effects to fish and will be submitted as a post-approval measure as agreed with the applicant." No such data have been found on the EMA website (2021-07-02).

Assessment report for formoterol and Riarify (beclometasone/formoterol/glycopyrronium bromide) 22 February 2018, EMA/155339/2018

Hazard

Persistence: No data.

Bioaccumulation: log K_ow -0.02.

Toxicitet: No data.

Risk

"PEC _{surfacewater, default} = 0.00012 microg/L. Conclusion: > 0.01 threshold (N)."

Fass environmental information

Fass environmental information for Oxis Turbuhaler (formoterol) from AstraZeneca (downloaded 2021-07-02).

Hazard

Persistence: Percentage DOC Removal 28 days 20.5%. Based on the data above and lack of further studies, the phrase “Formoterol fumarate dihydrate is potentially persistent” is chosen.

Bioaccumulation: Log D = 0.41 at pH 7.4.

Acute toxicity: There are data for 3 trophic levels, lowest for algae (Pseudokirchneriella subcapitata) 94 000 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.0000016 which gives the risk insignificant.