Important Safety Information

NeuroBloc® (Botulinum Toxin Type B) Injectable Solution is indicated for the treatment of cervical dystonia.

Before administering NeuroBloc®, clinicians should consult the full Prescribing Information.

The most frequently reported adverse events with NeuroBloc® in toxin-naïve and in patients with prior exposure to type A botulinum toxin are dry mouth and dysphagia. These adverse events are generally mild to moderate, transient, self-resolving, and more common with higher doses.

Dysphagia is commonly reported with all botulinum toxins in cervical dystonia patients.

Caution should be exercised when administering NeuroBloc® to individuals with motor neuron disease (eg, amyotrophic lateral sclerosis), peripheral motor neuropathic diseases (eg, motor neuropathy), neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) or history of dysphagia or aspiration. These patients may be at increased risk of clinically significant systemic effects including exaggerated muscle weakness, severe dysphagia and respiratory compromise from typical doses of NeuroBloc®. In these patients, rare cases of dysphagia severe enough to cause aspiration pneumonia or to warrant the insertion of a gastric feeding tube have also been reported.

Following NeuroBloc® treatment, all patients and caregivers should be advised to seek medical attention for respiratory difficulties, choking or any new or worsening dysphagia.

Coadministration of NeuroBloc® and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.

The safety and efficacy of NeuroBloc® have not been demonstrated in children.

In June 2007, a communication was sent to health care professionals advising of the risk of serious adverse events due to spread of botulinum toxins. If you would like to download a copy of this mailing please click here.