title: Piperaquine phosphate: reproduction studies.
abstract: In embryofetal studies in rat and rabbit Piperaquine phosphate (PQP) was not teratogenic at the maximal tolerated dose, even in presence of fetal exposure. In peri- post-natal study in rat, PQP did not interfere with the course of delivery at the dose of 5 mg/kg/day (treatment Gestation Day(GD)6-Lactation Day(LD)21) as well as up to the dose of 20 mg/kg/day (treatment GD6-17 and LD1-21). PQP at the dose of 80 mg/kg, induced prolonged gestation, dystocic delivery and increase perinatal mortality both with interruption of treatment (GD6 to GD17 and LD1-21) and with continuous dosing (GD19-LD21). PQP did not interfere with lactation and pup growth and development, in presence of clear exposure during suckling period, irrespective of the dose and treatment schedules. It was not possible to identify the mechanism leading to the delivery delay. In a comparative study using other antimalarials, only Mefloquine gave similar findings to PQP.
authors.affiliation: Accelera Srl, Viale Pasteur 10, 20014 Nerviano, Milan, Italy. monica.longo@accelera.org
authors.forename: Monica
authors.initials: M
authors.lastname: Longo
authors.forename: Silvia
authors.initials: S
authors.lastname: Pace
authors.forename: Monica
authors.initials: M
authors.lastname: Messina
authors.forename: Laura
authors.initials: L
authors.lastname: Ferraris
authors.forename: Marco
authors.initials: M
authors.lastname: Brughera
authors.forename: David
authors.initials: D
authors.lastname: Ubben
authors.forename: Guy
authors.initials: G
authors.lastname: Mazuè
mesh_terms: D000818:Animals; D000962:Antimalarials / Q000633:toxicity*; D005260:Female; D005865:Gestational Age; D007774:Lactation; D008431:Maternal-Fetal Exchange; D019055:No-Observed-Adverse-Effect Level; D036801:Parturition / Q000187:drug effects; D011247:Pregnancy; D011804:Quinolines / Q000633:toxicity*; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D012272:Ribs / Q000002:abnormalities; D010879:Piperazines
chemical_list: D000962:Antimalarials; D011804:Quinolines; C034759:piperaquine; D010879:Piperazines