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Rosuvastatin

Hazard 2 P 0 B 0 T 2 Risk Insignificant

Information

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

Fass environmental information

Fass environmental information for Crestor (rosuvastatin) (downloaded 2019-10-30).

Hazard

Persistence: "The evidence from the aquatic-sediment transformation study suggests that rosuvastatin calcium is degraded in the environment (DT50 < 32d)." See more details in the environmental information for Crestor. Conlusion: "Rosuvastatin calcium is degraded in the environment."

Bioaccumulation: "Since Log P < 4 at pH 7, the substance has been assigned the phrase: “Rosuvastatin calcium has low potential for bioaccumulation.”

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for crustacean (Daphnia magna) 18 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.023 which gives the risk insignificant.

Pharmaceutial residues in the aquatic environment

Rosuvastatin has been detected in treated wastewater in Region Stockholm in 2018. Concentrations varied between 27 and 116 ng/L. Rosuvastatin has also been found in treated wastewater in the Umeå area.

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