Hydrocortisone

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.

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, not all medicinal products containing the same active substance.

Assessment report for Plenadren

Assessment report for Plenadren (hydrokortison), DuoCort Pharma AB, 21 July 2011, EMA/CHMP/424438/2011.

"The PEC_surfacewater has been calculated to be 0.00662 µg/L using a DOSEai of 40 mg.inh^-1.d^-1 and default values for WASTEWinhab and DILUTION and this is below the EMEA action limit of 0.01µg/l. The Fpen value has been refined based on the following assumptions: The incidence of the disease i.e. the maximum number of patients that can be treated by Plenadren are 33.1 in a population of 100,000 inhabitants. Thus, out of a population of 500,000,000 in Europe (EU27) a maximum number of 165,500 can be treated with Plenadren per year. The maximum daily dose is 40 mg/day over 365 days. Therefore the total amount of Plenadren used over a year in the EU is 2416.6 kg. Using the calculation in the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (CHMP/SWP/4447/00) an Fpen value of 0.00031 % is calculated. Therefore, a Phase II assessment is not considered necessary. The logK_OW of hydrocortisone is below the threshold of 4.5 and consequently further investigation of the potential for persistence and bioaccumulation are not necessary. No other environmental concerns are apparent."

Assessment report for Efmody

Assessment report for Efmody (hydrocortisone), 25 March 2021, EMA/CHMP/233437/2021.

"According to the applicant, the bioaccumulation potential (log K_ow) is below 4.5. The Predicted Environmental Concentration in surface water (PEC_sw) is below the trigger value of 0.01. In addition, literature data indicate that hydrocortisone is readily biodegradable. The applicant concluded that the absence of tailored Phase II ERA with further studies could be justified. However the CHMP could not accept the published reference to support the ERA.

Therefore the CHMP, in the context of the obligation of the MAH to take due account of technical and scientific progress, the CHMP recommends the following points to be addressed post-authorisation:
- To provide a test on ready biodegradability. In case that hydrocortisone is readily biodegradable the tailored ERA can stop;
- To provide the study protocol or literature of the log K_ow data."No such information has been found on the EMA website (2024-10-18).

Assessment report for Alkindi

Assessment report for Alkindi (hydrocortisone), 14 December 2017, EMA/4145/2018.

"No Environmental Risk Assessment was submitted. This was justified by the applicant as the introduction of Alkindi manufactured by DIURNAL LTD is considered unlikely to result in any significant increase in the combined sales volumes for all hydrocortisone containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar and not increased. As the current product is an alternative formulation for hydrocortisone preparations that are currently authorised, a shift towards this formulation is anticipated, without impacting overall environmental exposure. Furthermore, the use of precise dose units as offered by Alkindi may reduce environmental exposure compared to existing hydrocortisone products used in this formulation, as there is the potential to prevent wastage from leftover portions after currently available tablets are cut up."

Fass environmental information

Fass environmental information for Xyloproct (hydrocortisone) from Aspen Nordic (downloaded 2024-10-18).

Hazard

Persistence: No data. 

Bioaccumulation: Log K_OW = 1.61.

Toxicity: No data.

Risk

Risk of environmental impact of hydrocortisonecannot be excluded, due to the lack of environmental toxicity data.

Report Goodpoint 2020

Comparative assessment of environmental risk when using the corticosteroids betamethasone, budesonide, hydrocortisone and prednisolone from a Swedish perspective.

The use of both betamethasone and budesonide poses an environmental risk, and exchange with synthetic glucocorticoids with a lower environmental risk is to be advocated in cases where it is possible from a clinical perspective. Hydrocortisone and prednisolone have a lower environmental risk but are rarely medically interchangeable alternatives to betamethasone and budesonide. Note that corresponding environmental risk assessments have not been made for other synthetic glucocorticoids that are available on the Swedish market, and which could possibly constitute exchange alternatives. No actions are recommended with regard to replacement of hydrocortisone and prednisolone as their use poses a low environmental risk given the current state of knowledge.