Persistence. Duloxetine is considered to be slowly degraded in the environment.
Bioaccumulation. Duloxetine has low potential for bioaccumulation.
Toxicity. Duloxetine has very high chronic toxicity.
Risk. The use of duloxetine (sales data Sweden 2020) has been considered to result in low environmental risk.
This summary information comes from Fass. The environmental impact of duloxetine is poorly studied according to report LS 2016–0634.
Fass environmental information
Fass environmental information for Cymbalta (duloxetine) from Lilly (downloaded 2023-03-01).
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 Kow at pH 7 = 1.54.
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for algae (Pseudokirchneriella subcapitata) 4.3 microg/L.
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 for Duloxetine Lilly 23 October 2014, EMA/753230/2014.
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.
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.
- Fass.se för vårdpersonal.
- European Medicines Agency. European public assessment report (EPAR) for Duloxetine Lilly 23 October 2014, EMA/753230/2014.
- Goodpoint. Prioritering av läkemedel med miljörisk inom SLL. Stockholm: Goodpoint; 2016. Rapport LS 2016–0634.
- Di Poi C, Evariste L, Serpentini A, Halm-Lemeille MP, Lebel JM, Costil K. Toxicity of five antidepressant drugs on embryo-larval development and metamorphosis success in the Pacific oyster, Crassostrea gigas. Environ Sci Pollut Res Int. 2014;21:13302-14.
- European Medicines Agency. European public assessment reports (EPAR).
- Provtagningar av läkemedelsrester i vatten, sediment och fisk för Region Stockholm.
- IVL Swedish Environmental Research Institute Ltd. Fick J, Lindberg RH, Kaj L, Brorström-Lundén E. Results from the Swedish National Screening Programme 2010. Subreport 3, B 2014 Pharmaceuticals.
- IVL Swedish Environmental Research Institute Ltd Fick J, Lindberg RH, Fång J, Magnér J, Kaj L, Brorström-Lundén E. Screening 2014. Analysis of pharmaceuticals and hormones in samples from WWTPs and receiving waters. Rapport C 135.
- Regon Stockholm. Kloka listan.
- Richmond EK, Rosi EJ, Walters DM, Fick J, Hamilton SK, Brodin T et al. A diverse suite of pharmaceuticals contaminates stream and riparian food webs. Nat Commun. 2018;9(1):4491.
Author: Health and Medical Care Administration, Region Stockholm