[e-farmacos] FDA Drug Safety Newsletter: nuevo boletin

["Madurga, Mariano" <mmadurga@agemed.es>]

Estimadas y estimados colisteros,

La FDA ha lanzado un nuevo boletin "Drug Safety Newsletter". Una respuesta de la FDA a las propuestas del Institute of Medicine que en su informe de sept 2006 Report on The Future of Drug Safety - Promoting and Protecting the Health of the Public  proponía cambios en la FDA sobre Seguridad de Medicamentos.

Volume 1 | Issue 1 | FALL2007

IN THIS ISSUE

2 WELCOME Introduction to the inaugural issue of the Drug Safety Newsletter from the Commissioner, Dr. Andrew C. von Eschenbach.

2 Editor's NoteOverview of the content of this issue of the Newsletter. 

POSTMARKETING REVIEWS

3 Rituximab Reports of progressive multifocal leukoencephalopathy associated with use of rituximab (marketed as Rituxan).

5 Modafinil of serious skin reactions associated with use of modafinil (marketed as Provigil).

7 Temozolomide Reports of aplastic anemia associated with use of temozolomide (marketed as Temodar). 

NEW MOLECULARENTITY (NME) - EARLY SAFETY FINDINGS

8 Deferasirox  Overview of reported adverse events of interest associated with the use of deferasirox, an oral chelating agent, in early postmarketing experience (marketed as Exjade).

9 DRUG SAFETY COMMUNICATIONS List of advisories on drug safety posted on FDA's Web site from January 1, 2007, through June 1, 2007, with related links.

Esta disponible en:
http://www.fda.gov/cder/dsn/default.htm

Un abrazo,

Mariano Madurga Sanz
Jefe de Servicio de Coordinación del SEFV
Division de Farmacoepidemiologia y Farmacovigilancia
Agencia Espanhola de Medicamentos y Productos Sanitarios
Correo-e: mmadurga@agemed.es  
Internet: www.agemed.es