Persistence. Alendronic acid is slowly degraded in the environment
Bioaccumulation. Alendronic acid has low potential for bioaccumulation.
Toxicity. Alendronic acid has low chronic toxicity.
Risk. The use of alendronic acid (sales data Sweden 2019) has been considered to result in insignificant environmental risk.
This summary information comes from Fass.
Fass environmental information
Fass environmental information for Alendronat Aurobindo Veckotablett from Orion Pharma (downloaded 2023-03-01). The environmental information for alendronic acid is produced by the company MSD for Fosamax, Fosamax Weekly Tablet and Fosamax mite. These medicines have been withdrawn from use. Fosamax Weekly tablet was withdrawn 2019-11-30 according to Fass.se.
Persistence: "Biotic degradation
Inherent degradability: Elimination of alendronate from the activated sludge test solutions occurred steadily over the 28-day test. Test substance concentrations decreased by 70.6% within 7 days and indicate that alendronate undergoes inherent primary biodegradation. Additionally, the 70.3% decline of TOC in the activated sludge indicates that alendronate also undergoes some ultimate biodegradation by converting to CO2. Therefore, alendronate can be classified as inherently, primarily biodegradable, without pre-adaption to the inoculum according to the OECD Guidelines and is not expected to persist in the environment. (OECD 302B).
Hydrolysis: Predicted hydrolysis half-life of 413, 375, and 223 days at pH 5, 7, and 9, respectively (US FDA 3.09).
Justification of chosen degradation phrase: Alendronate is classified as inherently, primarily biodegradable, therefore the phrase “Alendronate is slowly degraded in the environment” is thus chosen."
Bioaccumulation: Log K = -1.73 (OECD 107).
Toxicity: There are data for 3 trophic levels, most sensitive fish (Pimephales promelas) NOEC 32 d (growth)" = 1100 microg/L (OECD 210).
PEC/PNEC is based on sales data in Sweden in year 2019. PEC/PNEC = 0.0004 which gives the risk insignificant.
EMA's scientific discussion
EMA's scientific discussion about Fosavance (alendronic acid, colecalciferol), EMA 2005. "Based on an analysis of the environmental risk posed by the use of alendronate, no significant risk to the environment related to the use of the fixed combination is anticipated."
Author: Health and Medical Care Administration, Region Stockholm