Nimesulide: attenzione!
- 09 Ott 2007 alle 08:34:00
L’Irlanda ha sospeso la vendita dei farmaci a base di nimesulide dopo la segnalazione di sei casi di insufficienza epatica grave che hanno richiesto un trapianto di fegato dopo un uso prolungato. In Italia si è in attesa che l’EMEA (…) ne valuti la sicurezza.
La motivazione della sospensione in Irlanda è la seguente: «the indication for the use in children of metoclopramide (Primperan), a medicinal product to treat nausea and vomiting, has been tightened. This was due to the increase in registered cases of severe extrapyramidal symptoms
(movement disorders) in children.
The restricted indication is as follows: “Due to the high risk of extrapyramidal symptoms in children, metoclopramide is only indicated for severe nausea and vomiting of known origin, if treatment with other medicinal products has been ineffective or is not possible”».
La motivazione della sospensione in Irlanda è la seguente: «the indication for the use in children of metoclopramide (Primperan), a medicinal product to treat nausea and vomiting, has been tightened. This was due to the increase in registered cases of severe extrapyramidal symptoms
(movement disorders) in children.
The restricted indication is as follows: “Due to the high risk of extrapyramidal symptoms in children, metoclopramide is only indicated for severe nausea and vomiting of known origin, if treatment with other medicinal products has been ineffective or is not possible”».