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Esomeprazole

Hazard 1 P 0 B 0 T 1 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T comes from assessment report.

Assessment report

Assessment report for Nexium Control (esomeprazole), 27 June 2013, EMA/498929/2013.

Hazard

Persistence: Kd(ads) = 48, "DT50, water = 2.2 to 3.7, DT50, sediment = 3.1 to 6.8 (OECD 308)." According to expert, esomeprazole does not seem to be persistent (Researcher at the Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University 2018-09-05).

Bioaccumulation: log Kow < 4.5.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 1 mg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC = 0.1 microg/L.

PNEC = Lowest NOEC, 1 000 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 100 microg/L.

PEC/PNEC = 0.001 which gives the risk insignificant.

Fass environmental information

Fass environmental information for Nexium (esomeprazole) (downloade 2019-10-25)

Fara

Persistence: OECD 308: "Radiolabelled test substance was dosed into the overlying water and the subsequent dissipation from the water phase and partitioning and/or degradation in the sediment was observed over a 100 day test period, leaving less than 7 % of the parent substance in the sediment-water system. In both the high organic matter (HOM) and low organic matter (LOM) test vessels,esomeprazol was observed to be rapidly dissipated from the water phase and total system, with a half-life <14 days, respectively)." "The Kd(ads) was 48. Therefore, the substance has been assigned the phrase: “Esomeprazole is slowly degraded in the environment”."

Bioaccumulation: Log Dow < 4.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 1 mg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.0094 vwhich gives the risk insignificant.

Report Goodpoint 2019

Comparative assessment of environmental risk when using the gastric acid secretion inhibitors esomeprazole, lansoprazole, omeprazole, pantoprazole and ranitidine.

Even if one assumes a "worst-case" exposure (PEC) or based on measured levels in environmental/wastewater (below detection limits except for ranitidine), the margins are against either CEC (risk of interaction with target species in aquatic organisms, especially fish) or against established toxicity levels in aquatic organisms very large (lower than 0.001 for all substances). Thus, the environmental risk is insignificant for all the investigated substances in Swedish water. No exchanges are therefore recommended from an environmental point of view.

References

  1. European Medicines Agency. European public assessment reports (EPAR).
  2. Fass.se för vårdpersonal
  3. Goopoint. Jämförande bedömning av miljörisk vid användning av syrasekretionshämmarna esomeprazol, lansoprazol, omeprazol, pantoprazol samt ranitidin. Goodpoint; 2019-07-01.

Author: Health and Medical Care Administration, Region Stockholm