Showing posts with label natalizumab. Show all posts
Showing posts with label natalizumab. Show all posts

Monday, February 23, 2009

Updated Safety Information regarding Progressive Multifocal Leukoencephalopathy (PML) associated with TYSABRI® (natalizumab)

From Health Canada:
Biogen Idec Canada Inc., in consultation with Health Canada, would like to inform you that previously communicated safety information regarding post-marketing reports of PML in patients receiving TYSABRI® (natalizumab) monotherapy is now included in the Canadian Product Monograph. PML is a known risk of TYSABRI therapy.

TYSABRI is a humanized monoclonal antibody and is currently authorized as monotherapy (i.e. single disease-modifying agent) for the treatment of patients with relapsing-remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations, to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) scans and to delay the progression of physical disability.
For health care professionals
For the public

Thursday, February 19, 2009

Rare brain infection linked to MS drug

From CBC News:
There are reports of a rare brain infection among people taking the multiple sclerosis drug Tysabri, Health Canada warns.

The brain infection, called progressive multifocal leukoencephalopathy, or PML, usually happens in people with weakened immune systems.

Since Tysabri first came on markets several years ago, five people around the world who were taking the drug developed PML and one case resulted in death, Health Canada said Wednesday.

The drug has been approved for use in Canada since 2006 for the treatment of the relapsing-remitting form of MS, a progressive neurodegenerative disease.

In this type of MS, patients alternate between periods when they experience symptoms and when they don't. ...more

Wednesday, June 18, 2008

New Safety Information regarding Liver Injury and Hypersensitivity associated with TYSABRI (natalizumab)

From Health Canada:
Biogen Idec Canada Inc., in consultation with Health Canada, would like to inform you about new safety information regarding the risk of liver injury and hypersensitivity in patients receiving TYSABRI (natalizumab).
Tysabri For Health Professionals
For the Public