Other News New Advocacy Website Launched
Scientific Updates
FDA Approves Xeomin for the Treatment of Cervical Dystonia and Blepharospasm
Research Opportunity in Spasmodic Dysphonia
NSDA Funds New Research Grant on Spasmodic Dysphonia
Dystonia Awareness Week: June 6-12
Message from NSDA's New President - Charlie Reavis
The Congressionally Directed Medical Research Program Adds Dystonia to the List
NIH Funds $6.2 Million Dollar Grant for Focal Dystonias
Spasmodic Dysphonia and Quality of Life Research Study Results
Botulinum Toxin Update
NSDA Funds Research Grant
Brainstem Pathology in Spasmodic Dysphonia
Research Priorities in Spasmodic Dysphonia
Participate in the 2010 Dystonia Advocacy Day
Share Your Story Winner Announced
The Experience and Impact of Reading the "Share Your Story" Entries
Spasmodic Dysphonia Featured on ABC's Medical Mysteries Program
Changes in the Brain Identified in SD
SD Research Program Launched and Scientific Advisory Board Appointed
CEU Course Available on Spasmodic Dysphonia
Easier Done than Said...Living with a Broken Voice: New Book on Spasmodic Dysphonia
Emily Lim finds her Voice through Writing
Safety Issues Regarding Botulinum Toxin
ASHA provides Insurance Checklist for Speech Therapy Benefits
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Botulinum Toxin Update
The Food and Drug Administration (FDA) recently took measures to ensure that botulinum toxin products are used safely and appropriately. A mandatory “black box” warning label will be required for all botulinum toxin products sold in the United States. This will be applicable to currently approved formulations as well as new ones when they come to market in the future.
This is the most serious type of warning for prescription drug labeling, and it was added because of reports of serious muscle weakness along with speech, swallowing, and vision impairments in children with cerebral palsy. These children were being treated for spasticity with large doses of the product. While it was used off-label, similar effects have been reported in adults treated for both approved and unapproved uses.
In addition, all manufacturers of botulinum toxin products must implement a Risk Evaluation Management Strategy (REM) to ensure that physicians use the products knowledgably and patients must be informed of potential risks and provided with new information about the products. These actions are also taken to ensure that physicians know that botulinum toxin products available are measured in different units and therefore cannot be used interchangeably.
Currently, there are three botulinum toxin products approved for the treatment of various forms of dystonia. This includes Botox® manufacturedby Allegan (botulinum toxin type A), Myobloc® manufactured by Solstice (botulinum toxin type B), and most recently Dysport®, manufactured by Medicis Pharmaceutical Corp and Ipsen.
Dysport® has been recently approved for the treatment of cervical dystonia as well as an anti-wrinkle treatment. It is expected to launch for cervical dystonia during the second half of 2009. It has been used for both medical and cosmetic purposes in Europe and other parts of the world for over 10 years.
Another type A botulinum toxin, Xeomin®, manufactured by Merz Pharmaceuticals, is currently being reviewed by the FDA for the treatment of blepharospasm and cervical dystonia.
The NSDA recommends discussing any safety concerns you may have with a healthcare professional who is trained and experienced with injecting with botulinum toxin for spasmodic dysphonia.
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