Guest guest Posted March 8, 2008 Report Share Posted March 8, 2008 Arthritis & Rheumatism Volume 54, Issue 5, Pages 1429-1434 Published Online: 27 Apr 2006 Research Article Guillain-Barré and Fisher syndromes occurring with tumor necrosis factor alpha antagonist therapy In-Sook J. Shin 1, Alan N. Baer 1 *, Hyon J. Kwon 2, Elektra J. Papadopoulos 2, N. Siegel 2 1State University of New York at Buffalo 2Center for Drug Evaluation and Research, FDA, Silver Spring, land Abstract Objective Diverse neurologic syndromes have been described in association with tumor necrosis factor (TNF) antagonist therapy for inflammatory arthritides and Crohn's disease. The objective of this study was to review the occurrence and clinical features of Guillain-Barré syndrome and its variant, the Fisher syndrome, during TNF antagonist therapy. Methods The postmarketing database of the US Food and Drug Administration (FDA) was searched, following our experience with a patient with rheumatoid arthritis in whom the Fisher syndrome variant of the Guillain-Barré syndrome developed while he was receiving infliximab therapy. Results Our index patient had a neurologic illness defined initially by ataxia and dysarthria, which fluctuated in relation to each subsequent infliximab infusion and, after 6 months, culminated in areflexic flaccid quadriplegia. In addition, 15 patients in whom Guillain-Barré syndrome developed following TNF antagonist therapy were identified from the FDA database. Guillain-Barré syndrome developed following infliximab therapy in 9 patients, following etanercept therapy in 5 patients, and following adalimumab therapy in 1 patient. Among the 13 patients for whom followup data were available, 1 patient experienced no resolution, 9 patients had partial resolution, and 3 patients had complete resolution of Guillain-Barré syndrome following therapy. Conclusion An association of Guillain-Barré syndrome with TNF antagonist therapy is supported by the worsening of neurologic symptoms that occurred in our index patient following each infusion of infliximab, and by the temporal association of this syndrome with TNF antagonist therapy in 15 other patients. An acute or subacute demyelinating polyneuropathy should be considered a potential adverse effect of TNF antagonist therapy. http://www3.interscience.wiley.com/cgi-bin/fulltext/112598663/HTMLSTART -- Not an MD Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 8, 2008 Report Share Posted March 8, 2008 Yikes! This is why I try to throw away my package inserts w/o reading them! To the original poster who asked about neurological strangeness w/ Enbrel, last spring I did get numbness and tingling in my face and hands that necessitated a referral to neurology. My MRI and physical exam was normal, and it resolved within about 2 weeks. The confound was that I was switching from prednisone to dexamethasone, so I'm not sure if that had something to do with it. I hope you're feeling better and all the numbness has resolved, that must have been so scary for you. As for Guillain-Barre issue, my husband got it from his flu shot last year, so I know even tiny things can set off a weird neurological reaction. Kate F [ ] RESEARCH - Guillain-Barré and Fisher syndromes occurring with TNF-alpha antagonist therapy Arthritis & Rheumatism Volume 54, Issue 5, Pages 1429-1434 Published Online: 27 Apr 2006 Research Article Guillain-Barré and Fisher syndromes occurring with tumor necrosis factor alpha antagonist therapy In-Sook J. Shin 1, Alan N. Baer 1 *, Hyon J. Kwon 2, Elektra J. Papadopoulos 2, N. Siegel 2 1State University of New York at Buffalo 2Center for Drug Evaluation and Research, FDA, Silver Spring, land Abstract Objective Diverse neurologic syndromes have been described in association with tumor necrosis factor (TNF) antagonist therapy for inflammatory arthritides and Crohn's disease. The objective of this study was to review the occurrence and clinical features of Guillain-Barré syndrome and its variant, the Fisher syndrome, during TNF antagonist therapy. Methods The postmarketing database of the US Food and Drug Administration (FDA) was searched, following our experience with a patient with rheumatoid arthritis in whom the Fisher syndrome variant of the Guillain-Barré syndrome developed while he was receiving infliximab therapy. Results Our index patient had a neurologic illness defined initially by ataxia and dysarthria, which fluctuated in relation to each subsequent infliximab infusion and, after 6 months, culminated in areflexic flaccid quadriplegia. In addition, 15 patients in whom Guillain-Barré syndrome developed following TNF antagonist therapy were identified from the FDA database. Guillain-Barré syndrome developed following infliximab therapy in 9 patients, following etanercept therapy in 5 patients, and following adalimumab therapy in 1 patient. Among the 13 patients for whom followup data were available, 1 patient experienced no resolution, 9 patients had partial resolution, and 3 patients had complete resolution of Guillain-Barré syndrome following therapy. Conclusion An association of Guillain-Barré syndrome with TNF antagonist therapy is supported by the worsening of neurologic symptoms that occurred in our index patient following each infusion of infliximab, and by the temporal association of this syndrome with TNF antagonist therapy in 15 other patients. An acute or subacute demyelinating polyneuropathy should be considered a potential adverse effect of TNF antagonist therapy. http://www3. interscience. wiley.com/ cgi-bin/fulltext /112598663/ HTMLSTART -- Not an MD <!-- #ygrp-mkp{ border:1px solid #d8d8d8;font-family:Arial;margin:14px 0px;padding:0px 14px;} #ygrp-mkp hr{ border:1px solid #d8d8d8;} #ygrp-mkp #hd{ color:#628c2a;font-size:85%;font-weight:bold;line-height:122%;margin:10px 0px;} #ygrp-mkp #ads{ margin-bottom:10px;} #ygrp-mkp .ad{ padding:0 0;} #ygrp-mkp .ad a{ color:#0000ff;text-decoration:none;} --> <!-- #ygrp-sponsor #ygrp-lc{ font-family:Arial;} #ygrp-sponsor #ygrp-lc #hd{ margin:10px 0px;font-weight:bold;font-size:78%;line-height:122%;} #ygrp-sponsor #ygrp-lc .ad{ margin-bottom:10px;padding:0 0;} --> <!-- #ygrp-mlmsg {font-size:13px;font-family:arial, helvetica, clean, sans-serif;} #ygrp-mlmsg table {font-size:inherit;font:100%;} #ygrp-mlmsg select, input, textarea {font:99% arial, helvetica, clean, sans-serif;} #ygrp-mlmsg pre, code {font:115% monospace;} #ygrp-mlmsg * {line-height:1.22em;} #ygrp-text{ font-family:Georgia; } #ygrp-text p{ margin:0 0 1em 0;} #ygrp-tpmsgs{ font-family:Arial; clear:both;} #ygrp-vitnav{ padding-top:10px;font-family:Verdana;font-size:77%;margin:0;} #ygrp-vitnav a{ padding:0 1px;} #ygrp-actbar{ clear:both;margin:25px 0;white-space:nowrap;color:#666;text-align:right;} #ygrp-actbar .left{ float:left;white-space:nowrap;} ..bld{font-weight:bold;} #ygrp-grft{ font-family:Verdana;font-size:77%;padding:15px 0;} #ygrp-ft{ font-family:verdana;font-size:77%;border-top:1px solid #666; padding:5px 0; } #ygrp-mlmsg #logo{ padding-bottom:10px;} #ygrp-vital{ background-color:#e0ecee;margin-bottom:20px;padding:2px 0 8px 8px;} #ygrp-vital #vithd{ font-size:77%;font-family:Verdana;font-weight:bold;color:#333;text-transform:upp\ ercase;} #ygrp-vital ul{ padding:0;margin:2px 0;} #ygrp-vital ul li{ list-style-type:none;clear:both;border:1px solid #e0ecee; } #ygrp-vital ul li .ct{ font-weight:bold;color:#ff7900;float:right;width:2em;text-align:right;padding-ri\ ght:.5em;} #ygrp-vital ul li .cat{ font-weight:bold;} #ygrp-vital a{ text-decoration:none;} #ygrp-vital a:hover{ text-decoration:underline;} #ygrp-sponsor #hd{ color:#999;font-size:77%;} #ygrp-sponsor #ov{ padding:6px 13px;background-color:#e0ecee;margin-bottom:20px;} #ygrp-sponsor #ov ul{ padding:0 0 0 8px;margin:0;} #ygrp-sponsor #ov li{ list-style-type:square;padding:6px 0;font-size:77%;} #ygrp-sponsor #ov li a{ text-decoration:none;font-size:130%;} #ygrp-sponsor #nc{ background-color:#eee;margin-bottom:20px;padding:0 8px;} #ygrp-sponsor .ad{ padding:8px 0;} #ygrp-sponsor .ad #hd1{ font-family:Arial;font-weight:bold;color:#628c2a;font-size:100%;line-height:122%\ ;} #ygrp-sponsor .ad a{ text-decoration:none;} #ygrp-sponsor .ad a:hover{ text-decoration:underline;} #ygrp-sponsor .ad p{ margin:0;} o{font-size:0;} ..MsoNormal{ margin:0 0 0 0;} #ygrp-text tt{ font-size:120%;} blockquote{margin:0 0 0 4px;} ..replbq{margin:4;} --> ________________________________________________________________________________\ ____ Be a better friend, newshound, and know-it-all with Mobile. 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