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Reactions 1442 - 9 Mar 2013 Eisai warns of toxin spread with off-label use of Neurobloc Eisai has issued a Direct Communication to healthcare professionals in Ireland, regarding the risks associated with off-label use of Neurobloc [botulinum toxin type B]. Neurobloc is indicated for the treatment of torticollis (cervical dystonia) in adults. Eisai reports that there have been rare cases of distant toxin spread from the site of injection of Neurobloc, particularly associated with off- label use. When used as directed, for the approved indication, the majority of adverse effects attributable to toxin spread are self-limiting and do not require medical attention. However, severe adverse events have occurred, usually in association with incorrect or off- label use, such as use in children or patients with underlying neuromuscular deficits, or use of higher than recommended doses. Signs and symptoms of such toxin spread may include breathing difficulties, swallowing difficulties and choking. Patrikios T. Direct Healthcare Professional Communication on the risks associated with off-label use of NeuroBloc (botulinum toxin type B). Internet Document : 20 Feb 2013. Available from: URL: http://www.imb.ie 803084115 1 Reactions 9 Mar 2013 No. 1442 0114-9954/10/1442-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Eisai warns of toxin spread with off-label use of Neurobloc

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Page 1: Eisai warns of toxin spread with off-label use of Neurobloc

Reactions 1442 - 9 Mar 2013

Eisai warns of toxin spread withoff-label use of Neurobloc

Eisai has issued a Direct Communication tohealthcare professionals in Ireland, regarding the risksassociated with off-label use of Neurobloc [botulinumtoxin type B].

Neurobloc is indicated for the treatment of torticollis(cervical dystonia) in adults. Eisai reports that there havebeen rare cases of distant toxin spread from the site ofinjection of Neurobloc, particularly associated with off-label use.

When used as directed, for the approved indication,the majority of adverse effects attributable to toxinspread are self-limiting and do not require medicalattention. However, severe adverse events haveoccurred, usually in association with incorrect or off-label use, such as use in children or patients withunderlying neuromuscular deficits, or use of higher thanrecommended doses. Signs and symptoms of such toxinspread may include breathing difficulties, swallowingdifficulties and choking.Patrikios T. Direct Healthcare Professional Communication on the risks associatedwith off-label use of NeuroBloc (botulinum toxin type B). Internet Document : 20Feb 2013. Available from: URL: http://www.imb.ie 803084115

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Reactions 9 Mar 2013 No. 14420114-9954/10/1442-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved