Glibenclamide

Detailed information

Fass environmental information

Fass environmental information for Daonil (glibenclamide) from Sanofi AB (downloaded 2020-11-02).

Hazard

Persistence: "Inherent degradation: Test showed 5% degradation in 28 days (OECD 302B). [---] Glibenclamide fails to pass the criteria for inherent biodegradability which justifies the phrase “Glibenclamide is potentially persistent”."

Bioaccumulation: "Glibenclamide has high potential for bioaccumulation, as indicated by a Log P_ow of 4.79 (calculation Hansch/Leo method)."

Toxicity: There are data for 3 trophic levels, most sensitive algae (Desmodesmus subspicatus) NOEC 72 h (growth rate): 4 970 microg/l.

Risk

PEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 0.000017 which gives the risk insignificant.

Assessment report

Assessment report for Amglidia (glibenclamide) 22 February 2018, EMA/153558/2018.

Hazard

Persistence: No data.

Bioaccumulation: Log K_ow = 4.23.

Toxicity: No data.

Risk

PEC_surfacewater = 0.000032 microg/L.

"An adequate ERA in accordance with available guidance was performed. The predicted environmental concentration in surface water of glibenclamide is below 0.01 µg/l. The log K_ow is lower than 4.5, no further PBT assessment is required. In conclusion, Amglidia, in the proposed use, is not expected to pose a risk to the environment."

Report Goodpoint

In Sweden, glibenclamide has been found in wild fish in concentrations close to therapeutic concentrations in humans, which also is reasonable based on the substance solubility in fat and measured concentration in wastewater. Mechanism-based efficacy data is lacking.

Glibenclamide is included in Region Stockholm's table of pharmaceuticals with a negative environmental impact according to the environmental programme 2017–2021.

Suggestions on how to reduce the emissions of glibenclamide

Concrete proposals on how to work to reduce emissions of environmentally harmful pharmaceuticals on the list have been developed in close cooperation with the 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. (The Wise list is the drug formulary of essential medicines for common diseases in Region Stockholm from the Drug and Therapeutics Committee.) However, for such pharmaceuticals, there may be measures that could reduce the environmental impact.