Inadvertent oral administration of methylergometrine maleate to children in the first months of life: from surveillance to prevention

Autor: Fernanda Ferrazin, Laura Settimi, F. Giordano, Maria Luisa Casini, Franca Davanzo
Rok vydání: 2015
Předmět:
Zdroj: Pharmacoepidemiology and Drug Safety. 24:269-275
ISSN: 1053-8569
Popis: Purpose Methylergometrine maleate is an ergot alkaloid frequently used in obstetrics for prevention and treatment of post partum haemorrhage. Accidental administration of this medicine to newborns can cause severe effects and should be carefully prevented. The present paper is aimed at describing the main characteristics of cases accidentally exposed to this medicine in Italy before and after Novartis, the manufacturer of Methergin®, a widely used methylergometrine maleate-containing gynecological medication, decided to withdraw the drop preparation from the European market. Methods The study design is a case-series study. The database of the National Poison Control Centre of Milan was searched retrospectively (from 1 January 2005 to 31 December 2011) and prospectively (from 1 January 2012 to 31 December 2013) in order to provide a descriptive analysis of the main characteristics of cases unintentionally exposed to methylergometrine maleate and to document the impact of Novartis′ decision. Results In the first period under study (2005–2011), a total of 642 cases of exposure to methylergometrine maleate were identified. Most of them were children aged
Databáze: OpenAIRE