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Ezetimibe

Hazard 5 P 3 B 0 T 2 Risk Low

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T are from Fass. The risk is based on the report from Goodpoint 2019.

Fass environmental information

Fass environmental information for Atozet (ezetimibe) from MSD (downloaded 2019-10-30).

Hazard

Persistence: The DT50 for the total system is < 32 days with > 15% parent compound remaining at the end of the study therefore the phrase, “Ezetimibe is slowly degraded in the environment” is thus chosen.

Bioaccumulation: "Measured BCF values were 69 (low concentration) and 137 (high concentration) in a 97 day study with bluegill sunfish."

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 50 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.002 which gives the risk insignificant.

Pharmaceutical analyses of water

Ezetimib has been included included in monitoring schemes of purified wastewater and surface water 2018 in the Stockholm region but has not been detected.

National measurements of drug residues in water in Sweden

Ezetimibe has been detected in water for wastewater treatment plants. The reduction rate varied between more than 11 and 79%.

Report Goodpoint 2019

Comparative assessment of environmental risk when using simvastatin, atorvastatin, rosuvastatin, pravastatin and ezetimibe from a Swedish perspective.

Although there are knowledge gaps in particular regarding relevant toxicity studies, there is no obvious environmental risk with any of the investigated substances in Swedish water given the current state of knowledge. No exchanges are therefore recommended from an environmental point of view. The risk seems entirely insignificant for the highly water-soluble substance rosuvastatin. More fat-soluble statins (simvastatin, atorvastatin) may be quite potent and (together with ezetimibe) represent a slightly higher risk than the others, but the levels in the environment are probably well below the concentrations that give rise to effects. However, more impact studies are needed. For ezetimibe and pravastatin, efficacy data are even more deficient. For pravastatin, however, the risk was assessed based on its relatively low fat solubility (and thus the ability to accumulate in biota) in relation to its potency in humans. Ezetimibe is more fat-soluble, but at least partially separated in the wastewater treatment plants, how much is unclear due to high detection limits. Based on measured bioconcentration potential, there is some, but low risk for this substance.

Author: Health and Medical Care Administration, Region Stockholm