Guanfacine

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

Assessment report for Intuniv (guanfacine), 23 July 2015, EMA/CHMP/534329/2015.

Hazard

Persistence: OECD 308:
DT_{50 water} = 4.1/5.1 d (l/l)
DT_{50 sediment} = 58/118 d (l/l)
DT_{50 system} = 6.9/7.9 d (l/l)
Sediment shifting >10% at or after 14 days. l = lake, DT₅₀ values at 20°C; Significant shifting to sediment observed.

Bioaccumulation: log K_ow = 1.8.

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) NOEC 0.78 microg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC_{surface water}, default Fpen = 0.035 microg/L.

PNEC = Lowest NOEC, 0.78 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.078 microg/L

PEC/PNEC = 0.45 which gives the risk low.