New environmental information is published on fass.se for venlafaxine from Actavis (2018-07-10). However, in the new environmental information it is stated that data is missing with the exception of a literature estimated value of Log Pow. 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 information on risk comes from the reports by Goodpoint.
Persistence. Venlafaxine is slowly degraded in the environment.
Bioaccumulation. Venlafaxine does not have the potential to accumulate in aquatic organisms.
Toxicity. Venlafaxine has high acute toxicity.
Risk. See the reports from Goodpoint.
Fass environmental information for Venlafaxin Actavis (venlafaxine) from Teva (downloaded 2020-11-16).
Persistence: No data.
Bioaccumulation: There is an estimated value of Log Pow in the literature: 3.280, indicating that venlafaxine has low potential for bioaccumulation.
Toxicity: No data.
Risk of environmental impact of venlafaxine cannot be excluded, since no ecotoxicity data are available.
Fass environmental information for Efexor Depot (venlafaxine) from Pfizer (downloaded 2011-04-11).
Persistence: Venlafaxine is not expected to be degraded into the environment. This is based on the inherent degradation study according to OECD 302 A.
Bioaccumulation: Log Kow = 0.5 at pH 7.
Acute toxicity: There are data for 3 trophic levels, lowest for algae EC50 = 4.8 mg/L.
It is not clear which year of sales data that is based on the calculation of PEC/PNEC. PEC/PNEC = 0.060 which gives the risk insignificant, i.e. consideration has not been given to measured levels in the environment.
Levels of several SSRI/SNRI exceed the concentrations that have an influence on aquatic organisms, particularly invertebrates. However, studies with the very least effect concentrations have been questioned. Venlafaxine has been detected in fish exposed to purified wastewater, though in amounts below therapeutic drug levels in human.
Venlafaxine is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental program 2017–2021. Venlafaxine has been detected in treated wastewater and surface water i 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.
Concrete proposals on how to work to reduce emissions of environmentally harmful pharmaceuticals on the list have been developed in close cooperation with Region 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. (The Wise list is the drug formulary of essential medicines for common diseases in Region Stockholm from the Drug and Therapeutics Committee.) However, for such pharmaceuticals, there may be measures that could reduce the environmental impact.
Concrete proposal for venlafaxine
Author: Health and Medical Care Administration, Region Stockholm