Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Omeprazole

Hazard 4 P 3 B 0 T 1 Risk Insignificant

Information

The T-value in the score for hazard refers to acute toxicity. Underlying data for P, B and T comes from Fass.se. Esomeprazole is the S-enantiomer of the racemate omeprazole. See also esomeprazole.

Fass environmental information

Environmental information is missing on fass.se (2019-10-25). It is voluntary for manufacturers to provide information about environmental impact on fass.se. The information below is from Fass environmental information for Losec (omeprazole) (downloaded 2018-07-03).

Hazard

Persistence: "Omeprazole has been shown to undergo rapid abiotic degradation across the environmentally relevant pH range, with an abiotic half-life of <40 days. However, based on the data above (considering no other data is available), the substance has been assigned the risk phrase "Omeprazole is potentially persistent"."

Bioaccumulation: Log D = 2.24.

Acute toxicity: There are data for 3 trophic levels, lowest for fish (Danio rerio) 41.9 mg/L (OECD 203).

Risk

PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.018 which gives the risk insignificant.

Pharmaceutial residues in the aquatic environment

Omeprazole has previously been found in purified wastewater in Stockholm County (2005–2012). Omeprazole has not been analyzed in recent years.

Report Pharmaceutial residues in the Stockholm aquatic environment. Omeprazole has been detected in purified wastewater and in drinking water.

Report Goodpoint 2019

Comparative assessment of environmental risk when using the gastric acid secretion inhibitors esomeprazole, lansoprazole, omeprazole, pantoprazole and ranitidine from a Swedish perspective (Report Goodpoint 2019).

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.

Author: Health and Medical Care Administration, Region Stockholm