Safety Alerts & Recalls

What does this mean?

This alert highlights the importance of regularly reviewing the benefits and the risks of Abobotulinumtoxina with your doctor. Please review the Medication Guide that should be given to you by your doctor or nurse before you receive an injection of Abobotulinumtoxina. If you have any concerns about the risks and benefits of Abobotulinumtoxina, please discuss them with your doctor.

If you are receiving injections of Abobotulinumtoxina, 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 Abobotulinumtoxina.

FDA Approves Updated Labeling for Botulinum Products

FDA has concluded that the prescribing information for the botulinum toxin product AbobotulinumtoxinA (marketed as Dysport) must contain the following to ensure safe use of this product: 1) 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

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.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-08-04
Last Updated: 2009-12-05

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