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
Showing posts with label PML. Show all posts
Showing posts with label PML. Show all posts
Monday, February 23, 2009
Sunday, February 22, 2009
Drug maker suspends sale of psoriasis drug
From the Toronto Star:
The distributor of a psoriasis drug that is the subject of safety concerns has agreed to suspend sales of it in Canada.
Health Canada recommended that EMD Serono Canada Inc. stop the marketing of Raptiva, the brand name for the drug efalizumab.
Raptiva was authorized in October 2005 for treatment of moderate to severe chronic plaque psoriasis in patients 18 years of age and older.
But use of the drug has been linked to cases of a condition called progressive multifocal leukoencephalopathy or PML, a severe and sometimes fatal neurological disease.
And other serious infections have been seen in people who have taken the drug for three years or more, including Guillain-Barre syndrome, encephalitis, meningitis and sepsis, a bloodstream infection. ...more
The distributor of a psoriasis drug that is the subject of safety concerns has agreed to suspend sales of it in Canada.
Health Canada recommended that EMD Serono Canada Inc. stop the marketing of Raptiva, the brand name for the drug efalizumab.
Raptiva was authorized in October 2005 for treatment of moderate to severe chronic plaque psoriasis in patients 18 years of age and older.
But use of the drug has been linked to cases of a condition called progressive multifocal leukoencephalopathy or PML, a severe and sometimes fatal neurological disease.
And other serious infections have been seen in people who have taken the drug for three years or more, including Guillain-Barre syndrome, encephalitis, meningitis and sepsis, a bloodstream infection. ...more
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
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
Subscribe to:
Posts (Atom)