Levonorgestrel

Detailed information

Fass environmental information

Fass environmental information for Jaydess (levonorgestrel) from Bayer (downloaded 2025-03-12).

Hazard

Persistence: OECD 308: "Levonorgestrel was incubated in glass vessels containing sediment and overlaying water over 100 days. [...] The degradation rate was 6–7% at the end of the incubation period. The DT₅₀ (disappearance half-life from the water phase) for parent compound in water was estimated with 2.5 and 3.2 days for the fine and coarse sediment, respectively. This study reported a half-life of levonorgestrel in water DT₅₀ = 2.5–3.2 days while the DT₅₀ in sediment/total system could not be determined and the substance is considered potentially persistent in the environment." The database, Pharmaceuticals and Environment, reference group believes that based on these results, a drug substance is persistent and not potentially persistent, hence the information that levonorgestrel is persistent in the initial summary information.

Bioaccumulation: "Log P_OW 3.55 (Guideline FDA TAD 3.02). [...] According to the BCF of 119 to 250, levonorgestrel has low potential for bioaccumulation."

Toxicity: There are data for 3 trophic levels, most sensitive fish (zebrafish, Danio rerio) NOEC 126 days (reproduction) = 0.00016 microg/L (OECD 210).

Risk

PEC/PNEC is based on sales data in Sweden in year 2021. PEC/PNEC = 81.3 which gives the risk high.

Report Goodpoint 2016

Estimated levels in Swedish surface water may be sufficient to interfere with reproduction in fish. Fish exposed to purified effluent accumulates levonorgestrel to concentrations exceeding the serum concentrations achieved in women using birth control pills.

Levonorgestrel is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental program 2017–2021 based on lowest effect concentration, LOEC = 0.8 ng/L, and concentrations found in the environment.

Report Goodpoint 2024

In general, all progestogens occur in very low or undetectable concentrations in environments affected by municipal wastewater. Based on sales, the PEC is below 3 ng/L for all studied progestogens except for progesterone, medroxyprogesterone and drospirenone, but credible international measurements show that these three progestogens are also detected in concentrations around 1 ng/L in treated wastewater. At the same time, some progestogens are exceptionally potent with effects observed at exposures below 1 ng/L. However, only progestogens that bind strongly to the androgen receptor appear to be so potent in fish. Of the progestogens recommended in the Wise list (the formulary in Region Stockholm, Sweden), levonorgestrel, norethisterone, desogestrel and etonogestrel meet these criteria, while the other progestogens are considered to be less environmentally hazardous given the current state of knowledge. It is difficult, based on existing data, to stratify with certainty which of the androgenic progestogens are the most or least environmentally hazardous, even though norethisterone and levonorgestrel are somewhat better studied than desogestrel and etonogestrel. See also the report, which also lists various recommended alternatives in the Wise list, from best to worst from an environmental point of view.

The Wise list

Levonorgestrel is recommended 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.

Environmental classification of pharmaceuticals is taken into consideration, sometimes with other environmental aspects, when selecting pharmaceuticals for the Wise list. When comparable pharmaceuticals are equivalent to medical effects, safety and pharmaceutical efficacy, environmental impact and price are considered.

Suggestions on how to reduce the emissions of levonorgestrel

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. However, for such pharmaceuticals, there may be measures that could reduce the environmental impact.