August 17, 2001

Briefing Information

Safety Updates

Safety Update on TNF-a Antagonists:  Infliximab and Etanercept
First edition superceded by addendum below  pdf    

Addendum  pdf   htm

Mohan, Niveditha, Evelyn T Edwards, Thomas R Cupps, Patrick J Oliverio, Glenn Sandberg, Heidi Crayton, John R Richert, Jeffrey N Siege, "Demyelination occurring during anti-TNFa therapy for inflammatory arthritides." Manuscript*

Tables  pdf   xls   superceded by revised version  pdf   xls

EnbrelŪ (etanercept), Immunex Corporation and Wyeth-Ayerst Laboratories   pdf  

Remicade, Centocor   pdf


*May be viewed at:  Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland  20852, between the hours of 9 a.m. to 4:00 p.m. est, Monday through Friday, except for federal holidays.