Levofloxacin

Detailed information

Fass environmental information

Fass environmental information for Tavanic (levofloxacin) from Sanofi AB (retrieved on 2025-08-27).

Hazard

Persistence: No data.

Bioaccumulation: The substance has low bioaccumulation potential, as indicated by a calculated log K_ow value of -0.39.

Toxicity: There are data for 3 trophic levels, most sensitive cyanobacteria EC₁₀ 44 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2023.

PEC = 0.0088 microg/L.

PNEC = Lowest EC₁₀, 44 microg/L/10 (Assessment Factor (AF) 10 has been used see comment) = 4.4 microg/L. "Following the EMA guideline, the EC₁₀ has been used despite the absence of chronic data for daphnia and fish since there is a presence of an antibacterial substance. Cyanobacteria, Anabaena flos-aquae and an assessment factor of 10 has been used for this calculation since it is known to be the most sensitive species when it comes to antibacterial substances."

PEC/PNEC = 0.002 which gives the risk insignificant.

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.

The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, as well as possibly other products from the same company, not all medicinal products containing the same active substance.

Assessment report

Assessment report for Quinsair (levofloxacin), 18 December 2014, EMA/CHMP/676680/2014, Corr. 1.

Hazard

Persistence: No data.

Bioaccumulation: Log K_ow -0.20. Report No.RDF0013.

Toxicity: No data.

Risk

PEC_surfacewater, default or refined (e.g. prevalence, literature) = 0.00919 microg/L. Conclusion: Not exceeding the threshold value of 0.01 µg/L.

"The Phase I predicted environmental concentration (PEC) in surface water (PEC_SW) was calculated using a revised Fpen value based on the prevalence of CF in the EU (0.765/10,000) and using the prevalence of chronic PA infection in the total European Union (EU) population (0.497/10,000). The PEC_SW values for levofloxacin were 0.00919 and 0.00598 μg/L, respectively. However, the final assessment of the ERA cannot be concluded since the log K_ow should be determined experimentally as according to the relevant guideline. In the context of the obligation of the MAH to take due account of technical and scientific progress, the CHMP recommends the following points for further investigation to be addressed: "To conduct a study to experimentally determine the log K_ow (by end 1Q2015)"." No such data were found during a search of the EMA website (2025-08-27).

Comment

Levofloxacin has only undergone a phase I study in accordance with regulatory requirements for environmental risk assessments (Guideline on the environmental risk assessment of medicinal products for human use, EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.) A phase I study includes data on bioaccumulation and an estimation of the environmental concentration of levofloxacin (PEC_{Surface water}). If the specified threshold values are not exceeded, the company is not required to conduct a Phase II study, which includes data on toxicity, persistence, and risk assessment based on PEC/PNEC.

Other Information

Studies have shown that even low concentrations of antibiotics in the environment may trigger antibiotic resistance and should therefore be taken to ensure that as little as possible end up in our environment.