About Cervical Dystonia
Cervical dystonia is a neurological movement disorder that falls under the category known more generally as dystonia. Dystonia is characterized by involuntary, sustained muscle contractions that lead to repetitive movements and abnormal posture.1-3 Based on topical distribution, dystonias can be classified as follows3,4:
Focal: affecting only one region of the body
Segmental: affecting two or more adjoining regions of the body
Multi-focal: affecting two or more regions of the body that are not adjoining
Generalized dystonia: affecting several regions of the body that are not adjoining, including leg involvement
Hemidystonia: affecting one side of the body only
Cervical dystonia
Cervical dystonia (also called spasmodic torticollis) is the most common form of focal dystonia. It is estimated that cervical dystonia affects more than 125,000 people in the United States.5
Cervical dystonia affects the muscles of the head and neck, leading to pain and abnormal, or tonic, head and neck postures. Head movements may be equal, such as in a tremor, or unequal (rapid, clonic movements with slow recovery, termed spasmodic).2 Cervical dystonia may also affect the shoulder muscles.6
Cervical dystonia may be progressive, with symptoms beginning gradually and then reaching a plateau; although spontaneous remission may occur, sustained remissions are uncommon.7-9
Diagnosing cervical dystonia
Diagnosing cervical dystonia can be difficult, due to lack of specific clinical criteria and because its symptoms are associated with other conditions. However, it is important to properly diagnose and classify dystonia and the conditions with which it may be confused in order to provide appropriate treatment.10,11
Dystonia may present with a variety of different dystonic movements and postures, with specific features that can be recognized during a clinical examination. Diagnostic accuracy may be increased in consultation with a movement disorder specialist.
An MRI may also be necessary to rule out other conditions that may mimic the signs and symptoms of cervical dystonia. In some cases, specific types of dystonia may be identified using genetic testing or EMG mapping.10,11
Indication
Dysport is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients.
Important Safety Information
Distant Spread of Toxin Effect: Postmarketing reports indicate that the effects of Dysport and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
Dysport is contraindicated in patients with hypersensitivity to any botulinum toxin product or its excipients, including human albumin, lactose, and cow's milk protein, or who have an infection at the proposed injection site.
The potency Units of Dysport are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of Dysport cannot be compared to or converted into Units of any other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded.
Immediate medical attention may be required in cases of respiratory, speech, or swallowing difficulties. Dysphagia may persist for several weeks, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Concomitant neuromuscular disorder may exacerbate clinical effects of treatment.
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including severe dysphagia and respiratory compromise from typical doses of Dysport.
Dysport contains human albumin. Based on effective donor screening and product manufacturing processes, Dysport carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
The possibility of an immune reaction when injected intradermally is unknown. The safety of Dysport for the treatment of hyperhidrosis has not been established.
Patients receiving concomitant treatment of Dysport and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of botulinum toxin may be potentiated. Use of anticholinergic drugs may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxins during the course of treatment with Dysport is unknown.
There are no adequate and well-controlled studies in pregnant women. Dysport should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The most commonly observed adverse reactions (>5% of patients) with Dysport for the treatment of cervical dystonia are muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, injection site pain, and eye disorders.
To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Ipsen at 1-877-397-7671 (877- DYSPOR1). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed Warning, and Medication Guide.
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1. WE MOVE Web site. Overview of Dystonia. http://www.wemove.org/dys/dys.html. Accessed March 16, 2011. 2. WebMD Web site. Reynolds NC Jr, Ma J. Torticollis. http://emedicine.medscape.com/article/1152543-overview. Accessed March 16, 2011. 3. WebMD Web site. Moberg-Wolff EA, Thiyagarajah AR, Barna SA. Dystonias. http://emedicine.medscape.com/article/312648-overview. Accessed March 16, 2011. 4. WE MOVE Web site. Anatomical Distribution. http://www.wemove.org/dys/dys_anat.html. Accessed March 16, 2011. 5. ST/Dystonia Web site. Frequently Asked Questions. http://www.spasmodictorticollis.org/media/doc/DystoniaFAQSheet.doc. Accessed March 18, 2011. 6. ST/Dystonia Web site. What is ST? http://www.spasmodictorticollis.org/info/index.cfm. Accessed March 18, 2011. 7. Mayo Clinic Web site. Cervical Dystonia. http://www.mayoclinic.com/print/spasmodic-torticollis/DS00836/DSECTION=all&METHOD=print. Accessed March 18, 2011. 8. National Institutes of Health. Clinical Use of Botulium Toxin. http://consensus.nih.gov/1990/1990BotulinumToxin083html.htm. Accessed March 18, 2011. 9. Cleveland Clinic Web site. Diseases & Conditions. http://my.clevelandclinic.org/disorders/dystonia/hic_dystonias.aspx. Accessed March 15, 2011. 10. Albanese A, Barnes MP, Bhatia KP, et al. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force. Eur J Neurol. 2006;13:433-444. 11. Elia AE, Lalli S, Albanese A. Differential diagnosis of dystonia. Eur J Neurol. 2010;17(suppl 1):1-8.
