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Update of Safety Review of OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc)
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
FDA has completed its safety review of botulinum toxin products and approved the revisions to the prescribing information and the Risk Evaluation and Mitigation Strategies (REMS) for Botox/Botox Cosmetic and Myobloc. The revised information now includes a Boxed Warning and a Medication Guide that highlight the risk, shared by all of the botulinum toxin products, of spread of toxin effect from the area of injection, causing symptoms similar to those of botulism. The other botulinum toxin product in this class, Dysport, was approved on April 29, 2009 and included the Boxed Warning and REMS for the class of botulinum toxin products at the time of approval.
In addition, the FDA, along with the United States Adopted Names Council (USAN), has agreed to the revised established names for each botulinum toxin product to reinforce the understanding that each product has an individual potency and is not interchangeable with any other product.