Assessment of the environmental fate and effects of the PPARgamma receptor agonist, pioglitazone

The environmental fate and effects of pioglitazone prescribed for the treatment of type 2 diabetes were evaluated in an environmental risk assessment following the European Medicines Agency (EMA) “Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use”; EMEA/CHMP/SWP/4447/00. A predicted environment concentration (PEC) for surface water was estimated at 0.023 μg L−1, (action limit of 0.01 μg L−1) triggering a comprehensive battery of laboratory evaluations. Pioglitazone and its major metabolites were determined not to significantly adsorb to sewage solids, were not persistent in the aquatic environment, did not bioaccumulate and were non-toxic to aquatic organisms. Pioglitazone does not pose an unacceptable risk to groundwater supplies, with concentrations not anticipated to be a risk to aquatic organisms or human drinking water supplies. Pioglitazone does not pose a risk of secondary poisoning.

Research highlights
► The calculated PECsurfacewater for pioglitazone is 0.023 μg L−1.
► Pioglitazone and its major metabolites do not adsorb to sewage solids.
► Pioglitazone does not persist in the aquatic environment and does not bioaccumulate.
► Pioglitazone is non-toxic to aquatic organisms.
► Pioglitazone poses no unacceptable risk to groundwater or human drinking water.