Environmental information about fluoxetine is missing on fass.se (2020-11-02). It is voluntary for manufacturers to provide information about environmental impact on fass.se. The data on persistence, bioaccumulation and toxicity are based on previous environmental information on Fass.se. The risk comes from the reports by Goodpoint.
Persistence. Fluoxetine is potentially persistent.
Bioaccumulation. Fluoxetine has low potential for bioaccumulation.
Toxicity. Fluoxetine has very high chronic toxicity.
Risk. See the reports by Goodpoint.
Fass environmental information for Fontex (fluoxetine) from Lilly (downloaded 2018-07-10).
Persistence: "Fluoxetine disappeared from the total system with DT50 values of 32 days (lake sediment) and 114 days (creek sediment) which is likely due, in part, to unextractable binding to the sediment. Fluoxetine slowly disappears from water sediment systems. [---] The degradation phrase "Fluoxetine is potentially persistent" is based on the absence of a standard water sediment degradation study and the lack of ready and inherent biodegradability.”
Bioaccumulation: "The log of the octanol water partition coefficients at pH values of 5, 7, and 9 were 0.73 to 1.06, 1.77 to 1.79, and 2.62 to 2.64, respectively."
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Danio rerio) 3.2 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2014. PEC/PNEC = 0.2 which gives the risk low.
Fluoxetine is an SSRI, selective serotonin reuptake inhibitor. The concentrations analyzed in the environment in Sweden by several SSRIs exceed reported levels of environmental impact, especially for invertebrates. However, the studies reporting the lowest effect concentrations are questioned. Fluoxetine has been found in wild fish, but not at levels corresponding to therapeutic levels in humans.
Fluoxetine is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental programme 2017–2021. The substance has been detected in treated wastewater in Region Stockholm.
Comparative assessment of environmental risk in the use of citalopram, escitalopram, sertraline, fluoxetine, venlafaxine, paroxetine and clomipramine in Sweden.
Overall, there is a risk profile for the studied antidepressants.
Fluoxetine is recommended in the Wise list. The Wise list is the drug formulary of essential medicines for common diseases in Region Stockholm from the Drug and Therapeutics Committee. 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.
Concrete proposals on how to work to reduce emissions of environmentally harmful pharmaceuticals on the list have been developed in close cooperation with the Stockholm Drug and Therapeutics Committee's expert groups. The action proposals were developed from an environmental perspective. The patient's best always goes first and several pharmaceuticals on the list are also included in the Wise list. However, for such pharmaceuticals, there may be measures that could reduce the environmental impact.
Concrete proposal for fluoxetine
Author: Health and Medical Care Administration, Region Stockholm