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FDA MedWatch

Rituzan (rituximab)- Important New Safety Information Regarding Progressive Multifocal Leukoencephalopathy With The Use Of Rituxan

09/11/2008- LifePak CR Plus Automated External Defibrillators- Class I Recall Because The Shock Button Is Not Visible Which Impedes Responder's Ability To Provide Shock Therapy

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.   Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and updated prescribing information for Rituxan regarding the above issue at:   

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Rituxan

 

 

 
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