Drugs Xagena
Botulinum toxin type B ( Neurobloc ) is indicated only for the treatment of cervical dystonia ( torticollis ) in adults. MHRA ( Medicines and Healthcare Products Regulatory Agency ) recommends that prescribers adhere to the licensed indication as its safety outside these circumstances has not been established.
Cases of the known rare risk of toxin spread have been reported with all Botulinum toxin products. Importantly, the cases with Botulinum toxin type B were mostly reported with its off-label use.
All patients receiving any product containing Botulinum toxin should be warned of the signs and symptoms of toxin spread, such as muscle weakness and breathing difficulties, and advised to seek medical attention immediately if they experience breathing difficulties, choking, or any new or worsening swallowing difficulties, as such side effects may be life-threatening.
Neurobloc is indicated only for the treatment of cervical dystonia in adults. The safety of Botulinum toxin type B has not been established outside this licensed indication.
Rare cases of distant toxin spread from the site of injection have been reported with Botulinum toxin type B ( and Botulinum toxins as a class ).
Some of the cases with Botulinum toxin type B occurred in patients with underlying neuromuscular deficits, in children, and other off-label use. Medically severe adverse reactions related to the spread of toxin, such as dysphagia and breathing difficulties have usually occurred in association with incorrect clinical use or off-label use, such as the use in children or patients with significant neuromuscular disease, or the use of higher than recommended doses.
Advice for healthcare professionals
Reported cases of toxin spread with Botulinum toxin type B have mostly occurred with off-label use; MHRA therefore recommends that prescribers adhere to the licensed indication.
Botulinum toxin type B should not be used in children, or in patients with known neuromuscular disease or neuromuscular junction disorders.
The risk of toxin spread with Botulinum toxins is rare but serious and has been reported with all products in this class. All patients receiving a medicine containing Botulinum toxin should be warned of the signs and symptoms of toxin spread, such as muscle weakness and breathing difficulties, and advised to seek medical attention immediately if they experience breathing difficulties, choking, or any new or worsening swallowing difficulties, as such side effects can be life-threatening. ( Xagena )
Source: Drug Safety Update 2013 vol 6, issue 8: A3
XagenaMedicine_2013
