OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc) Information

FDA ALERT [08/2009]: As announced on April 30, 2009, based on a safety evaluation of the botulinum toxin products, FDA has concluded that the prescribing information for OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic) and RimabotulinumtoxinB (marketed as Myobloc) must be updated to ensure their continued safe use.  On July 31, 2009, FDA, under the authorities granted by the Food and Drug Administration Amendments Act (FDAAA) of 2007, approved the following revisions to the prescribing information of Botox/Botox Cosmetic and Myobloc:

• A Boxed Warning highlighting the possibility of experiencing potentially life-threatening distant spread of toxin effect from the injection site after local injection. 

• A Risk Evaluation and Mitigation Strategy (REMS) that includes a Medication Guide to help patients understand the risks and benefits of botulinum toxin products.

• Changes to the established drug names to reinforce individual potencies and prevent medication errors.  The potency units are specific to each botulinum toxin product, and the doses or units of biological activity cannot be compared or converted from one product to any other botulinum toxin product.  The new established names reinforce these differences and the lack of interchangeability among products.

 The other botulinum toxin product in this class, AbobotulinumtoxinA (marketed as Dysport), was approved on April 29, 2009 and included the Boxed Warning, REMS, and new established name at the time of approval.

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To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program using the information at the bottom of this page.