Lidocaine

Detailed information

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 can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

Assessment report Lidocaine/Prilocaine Plethora

Assessment report for Lidocaine/Prilocaine Plethora (lidocaine, prilocaine), Plethora Solutions Ltd., 19 September 2013, EMA/685541/2013.

Hazard

Persistence: No data.

Bioaccumulation: Log K_ow = 2.26.

Toxicity: No data.

Risk

PEC_surfacewater = 0.0052. "Lidocaine/Prilocaine PEC_surfacewater value is below the action limit of 0.01 µg/L and is not a PBT substance as log Kow does not exceed 4.5. Therefore Lidocaine/Prilocaine is not expected to pose a risk to the environment."

Assessment report Senstend

Assessment report for Senstend (lidocaine, prilocaine), Plethora Pharma Solution Limited, 19 September 2019, EMA/625405/2019.

"Since this application is an informed consent application, the medicinal product subject to this application is intended to be administered at comparable dose levels and for indications that were already approved in the Union for Fortacin. Based on the assumption that Senstend cutaneous spray, solution is intended to substitute for identical products on the market and it is unlikely to result in any significant increase in combined sales volumes, the approval of the product does not result in an increase of the total quantity of the active ingredients released into the environment. This justification is considered acceptable and in accordance with the Guideline on the environmental risk assessment of medicinal products for human uses (EMEA/CHMP/SWP/4447/00)."

Comment on Fass environmental information

Lidocaine has different classifications on fass.se. According to Lif (the trade association for the research-based pharmaceutical industry in Sweden) the various pharmaceutical companies compile environmental information for their active substances based on internal studies and published data. Based on data, which may thus differ between different pharmaceutical companies, the companies assess the environmental risk with guidance from “Environmental classification of pharmaceuticals at www.fass.se – Guidance for pharmaceutical companies 2012”. The Swedish Environmental Institute (IVL) reviews the assessment but does not have the task of coordinating/harmonizing environmental information from different pharmaceutical companies for the same active substance.

Fass environmental information for Rocephalin med lidokain

Fass environmental information for lidocaine from Rocephalin med lidokain (ceftriaxone, lidocaine), Roche (downloaded 2022-02-09).

Hazard

Persistence: "Degradation in surface water t½ = 92 d (laboratory, 23 °C, in the dark), t½ = 110 d (field, 2–28 °C, in the dark). Abiotic Degradation: Photodegradation: t½ = 0.4 d (laboratory, light), t½ = 1.3 d (field, light). Lidocaine is neither readily, nor inherently biodegradable. This justifies the phrase 'Lidocaine is potentially persistent.'"

Bioaccumulation: "logP_OW 1.66 QSAR; logP_OW 2.44 method unknown; logD_OW 1.63 (pH 7.4, 25 °C); logD_OW 1.66 (phosphate buffer, pH 7.4, 25 °C); KOC ≤420 QSAR; BCF <20 QSAR. Lidocaine has low potential for bioaccumulation (log D_OW <4 at pH 7.4)."

Acute toxicity: There are data for 3 trophic levels, most sensitive fish (Danio rerio) LC₅₀ 24 h (mortality) = 23 mg/L (OECD 236, adapted).

Risk

PEC/PNEC is based on sales data in Sweden in year 2020. PEC/PNEC = 0.007 which gives the risk insignificant.

Fass environmental information for Depo-Medrol cum lidocain

Fass environmental information for lidocaine from Depo-Medrol cum lidocain (lidocaine, methylprednisolone) from Pfizer (downloaded 2022-02-09).

Hazard

Persistence: No data.

Bioaccumulation: No data.

Acute toxicity: No data.

Risk

Risk of environmental impact of lidokainhydrochloride cannot be excluded, due to the lack of environmental toxicity.

Manufacturer has on fass.se stated that data about the environmental impact is missing for the substance so that the environmental risk cannot be calculated. It is voluntary for manufacturers to provide information on the environmental impact on fass.se.