Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.
Source: http://www.fda.gov/medwatch/safety/2008/rituxan_DHCP_Final%209411700.pdf
Showing posts with label Rituximab. Show all posts
Showing posts with label Rituximab. Show all posts
Saturday, November 1, 2008
Wednesday, September 19, 2007
Progressive Multifocal Leukoencephalopathy (PML) associated with Rituximab
A safety review on rituximab identified an association of the drug with a serious adverse event, progressive multifocal leukoencephalopathy (PML), a viral infection of the central nervous system. The product labeling has been updated to reflect this new safety information, and a public health advisory and information for healthcare professionals have been posted on FDA's Web site.
As of December 2006, FDA has received a total of 24 reports of PML in patients who received rituximab treatment.
Source: http://www.fda.gov/cder/dsn/2007_fall/postmarketing.htm#Rituximab
As of December 2006, FDA has received a total of 24 reports of PML in patients who received rituximab treatment.
Source: http://www.fda.gov/cder/dsn/2007_fall/postmarketing.htm#Rituximab
Subscribe to:
Posts (Atom)
