Crohn's News Blog

Weblog – Informação sobre DII

Posts Tagged ‘PML

FDA confirma 3 novos casos relacionados com Tysabri

leave a comment »

FDA confirma 3 novos casos relacionados com Tysabri

A Food and Drug Administration (FDA) confirma três novos casos de uma inflamação cerebral potencialmente letal ligada ao medicamento Tysabri para a esclerose múltipla.

FDA confirms 3 new infections linked to Tysabri

TYSABRI® - O fármaco foi aprovado em Novembro de 2004 e retirado do mercado no ano seguinte (2005) devido a relatos PML. Foi reintroduzida em Julho de 2006, a Biogen informou que o Tysabri é usado por 43.000 pacientes

.
NEW YORK (AP)— The Food and Drug Administration says it confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri.

There have been 13 reported cases of progressive multifocal leukoencephalopathy, or PML, since mid-2006. The reports are the first confirmed new cases since June. While the disease is rare, the FDA says the risk appears to increase as patients remain on Tysabri.

Tysabri is marketed by Biogen Idec Inc. and Elan Corp. PLC, for multiple sclerosis and Crohn’s disease. All the PML cases are linked to its use in multiple sclerosis.

The drug was approved in November 2004 and pulled from the market the next year due to PML reports. It was reintroduced in July 2006, and Biogen said it is used by 43,000 patients.

AP Copyright © 2009
.
.
.
.


http://www.attorneyatlaw.com/2009/09/tysabri-problems-continue-now-13-reports-of-brain-infection-fda-says/

via FDA confirma 3 novos casos relacionados com Tysabrishare-button

Written by CarlAn

23/09/2009 at 11:50

%d bloggers like this: