OBJECTIVE: To evaluate the teratogenic or fetal risk of a long-acting GnRH agonist (GnRH-a) triptoreline acetate (Decapeptyl; Ipsen-Biotech, Inc., Paris, France), inadvertently administrated in the first weeks of pregnancy. DESIGN: Prospective follow-up of exposed pregnancies and case reports. SETTING: Teratology information service of a public hospital and pharmacovigilance department of the firm. PATIENTS: Inadvertent pregnant women receiving a treatment, mainly for endometriosis or IVF. INTERVENTIONS: Case by case, individual estimations of the risks have been provided. MAIN OUTCOME MEASURE: Each pregnancy issue has been analyzed. RESULTS: No teratogenic or fetal toxic effect has been noted. CONCLUSION: No specific hazard has been observed among newborns after inadvertent exposures to a GnRH-a during the first 20 weeks of pregnancy.
OBJECTIVE: To evaluate the teratogenic or fetal risk of a long-acting GnRH agonist (GnRH-a) triptoreline acetate (Decapeptyl; Ipsen-Biotech, Inc., Paris, France), inadvertently administrated in the first weeks of pregnancy. DESIGN: Prospective follow-up of exposed pregnancies and case reports. SETTING: Teratology information service of a public hospital and pharmacovigilance department of the firm. PATIENTS: Inadvertent pregnant women receiving a treatment, mainly for endometriosis or IVF. INTERVENTIONS: Case by case, individual estimations of the risks have been provided. MAIN OUTCOME MEASURE: Each pregnancy issue has been analyzed. RESULTS: No teratogenic or fetal toxic effect has been noted. CONCLUSION: No specific hazard has been observed among newborns after inadvertent exposures to a GnRH-a during the first 20 weeks of pregnancy.
Authors: Joanne E Given; Maria Loane; Johannes M Luteijn; Joan K Morris; Lolkje T W de Jong van den Berg; Ester Garne; Marie-Claude Addor; Ingeborg Barisic; Hermien de Walle; Miriam Gatt; Kari Klungsoyr; Babak Khoshnood; Anna Latos-Bielenska; Vera Nelen; Amanda J Neville; Mary O'Mahony; Anna Pierini; David Tucker; Awi Wiesel; Helen Dolk Journal: Br J Clin Pharmacol Date: 2016-07-07 Impact factor: 4.335