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Fesoterodine

Hazard 0 P 0 B 0 T 0 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity. The data on hazard and risk are based on previous environmental information on fass.se. Environmental information is missing on fass.se (2019-12-04). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Scientific discussion

Scientific discussion for Toviaz (fesoterodine) states the following: "As per the guideline, a Phase I estimation of exposure based on the fesoterodine fumarate maximum daily dose of 8 mg and the default Fpen value of 0.01, results in a PECsurfacewater =0.04 μg/L, which is > the Action limit of 0.01 μg/L. Therefore, a Phase II assessment is currently underway and will be submitted as a post-approval commitment, 2Q07." According to contact with the Swedish Medical Products Agency, data have been received (e-mail 2019-09-16) with partly the same information presented below in Fass's environmental information for Toviaz 2011-05-12.

Fass environmental information

Fass environmental information for Toviaz (fesoterodine) from Pfizer (downloaded 2011-05-12).

Hazard

Persistence: "The results of the water/sediment studies show that [14C]-SPM 7605 steadily depletes with time from the water-sediment system with notable biotransformation observed in both the aerobic and anaerobic systems. Once in the sediment, degradation continued at a slower rate under anaerobic conditions. At study termination of 100 days, none of the metabolic products exceeded 10% under aerobic conditions, and complete mineralisation of SPM 7605 is expected with time. These results indicate that SPM 7605 will not persist in the environment."

Bioaccumulation: Log Kow = 0 at pH 7.

Toxicity: There are data for 3 trophic levels, most sensitive green algae NOEC 2 200 microg/L.

Risk

PEC / PNEC is based on sales data in Sweden but unclear during which year. PEC/PNEC = 0.1 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm