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Duloxetine

Hazard 6 P 3 B 0 T 3 Risk Low

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B, T and risk are from Fass.

The environmental impact of duloxetine is poorly studied according to report LS 2016–0634.

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."

Below is Hazard and Risk from Fass environmental information for Cymbalta (duloxetine) (downloaded 2018-09-17)

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 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.

Risk

PEC/PNEC is based on sales data in Sweden in year 2014. PEC/PNEC = 0.23 which gives the risk low.

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 not detected in SLL's latest measurement of pharmaceutical residues in water 2017.

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.

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.

Author: The Pharmaceutical unit of Region Stockholm