Safety Alert: Onabotulinumtoxina
FDA Approves Updated Labeling for Botulinum Products
As first announced in an iGuard alert on May 1, 2009, the FDA has concluded that the prescribing information for the botulinum toxin product OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic) must be updated to ensure safe use of this product. The FDA approved the final revisions to the prescribing information of Botox and Botox Cosmetic:
1) Addition of a Boxed Warning highlighting the possibility of potentially life-threatening spread of toxin from the injection site
2) Distribution of a Medication Guide to help patients understand the risks and benefits of botulinum toxin product
3) Changing the active ingredient name from "Botulinum toxin type A" to "OnabotulinumtoxinA" to reduce medication errors. The marketed trade name of Botox and Botox Cosmetic and the product formulations will not changed for these product
Please be aware that the available botulinum toxin products (Botox/Botox Cosmetic, Dysport, and Myobloc) differ from one another in dose units, names, and dosing and are NOT interchangeable.
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What does this mean?
This alert highlights the importance of regularly reviewing the benefits and the risks of Onabotulinumtoxina with your doctor. Please review the Medication Guide that should be given to you by doctor or nurse before you receive an injection of Onabotulinumtoxina. If you have any concerns about the risks and benefits of Onabotulinumtoxina, please discuss them with your doctor.
If you are receiving injections of Onabotulinumtoxina, pay close attention for any signs or symptoms of side effects which may occur within hours of an injection or as late as several weeks after treatment. Seek immediate medical attention if you have unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness following treatment with Onabotulinumtoxina.
