title: Assessment of the environmental fate and effects of the PPARgamma receptor agonist, pioglitazone.
abstract: 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 0.023μgL(-1), (action limit of 0.01μgL(-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.
authors.affiliation: Takeda Global Research & Development Center, Inc., One Takeda Parkway, Deerfield, IL 60015, USA. bweltman@tgrd.com
authors.forename: Robert
authors.initials: R
authors.lastname: Weltman
authors.forename: Tom
authors.initials: T
authors.lastname: Hargreaves
authors.forename: Brian
authors.initials: B
authors.lastname: Knight
authors.forename: Laura
authors.initials: L
authors.lastname: Wardrope
mesh_terms: D000818:Animals; D000460:Chlorophyta / Q000187:drug effects; D003530:Cyprinidae / Q000378:metabolism; D003621:Daphnia / Q000187:drug effects; D005618:Fresh Water / Q000737:chemistry; D019015:Geologic Sediments / Q000737:chemistry; D007004:Hypoglycemic Agents / Q000032:analysis* / Q000378:metabolism / Q000633:toxicity; D007700:Kinetics; D047495:PPAR gamma / Q000819:agonists*; D000077205:Pioglitazone; D018570:Risk Assessment; D045162:Thiazolidinediones / Q000032:analysis* / Q000378:metabolism / Q000633:toxicity; D014865:Waste Disposal, Fluid; D014874:Water Pollutants, Chemical / Q000032:analysis* / Q000378:metabolism / Q000633:toxicity; D014877:Water Pollution, Chemical / Q000706:statistics & numerical data
chemical_list: D007004:Hypoglycemic Agents; D047495:PPAR gamma; D045162:Thiazolidinediones; D014874:Water Pollutants, Chemical; D000077205:Pioglitazone