Duloxetine

Detailed information

Fass environmental information

Fass environmental information for Cymbalta (duloxetine) from Lilly (downloaded 2023-03-01).

Hazard

Persistence: "Since the calculated DT₅₀ in one sediment system was less than 120 days (78,2 days) and the other was greater than 120 days (240.7 days), duloxetine is considered to be slowly degraded in the environment."

Bioaccumulation: log K_ow at pH 7 = 1.54.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for algae (Pseudokirchneriella subcapitata) 4.3 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2014. PEC/PNEC = 0.23 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 Duloxetine Lilly 23 October 2014, EMA/753230/2014.

Hazard

Persistence and bioaccumulation:No data is reported. "The data showed that duloxetine would not persist or accumulate in aqueous, sediment or soil compartments."

Chronic toxicity: No data.

Risk

No data about PEC/PNEC. "Additionally, the predicted environmental concentrations of duloxetine were lower than the predicted no-effect concentrations calculated from ecotoxicity data with sentinel species. The conclusions in the environmental risk assessments state that human excretion of duloxetine and its metabolites is not expected to result in any significant environmental risk."

Pharmaceutical analyses of water in Stockholm County

Duloxetine has been detected in raw water and drinking water in Stockholm County in 2012–2016. Duloxetine was last detected in outgoing wastewater in 2019.

Pharmaceutical analyses of water from a national perspective

Duloxetine levels in the aquatic environment were below detection limits in 2014, while levels up to 14 ng/L were detected in a previous screening of the effluent from wastewater treatment plants. Amounts measured in sludge were up to 28 microg duloxetine/kg.

Duloxetine and spiders

Duloxetine has been found in spiders (article Richmond et al. 2018).

The Wise list

Is recommended in the Wise list. Environmental classification of pharmaceuticals is taken into consideration, sometimes with other environmental aspects, when selecting pharmaceuticals for the Wise list. When comparable pharmaceuticals are equivalent to medical effects, safety and pharmaceutical efficacy, environmental impact and price are considered.