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Update of Safety Review of OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc)

The 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 manufacturers of Botox/Botox Cosmetic and Myobloc were informed on April 29, 2009 that these revisions were required to assure safe use of these products. 

The revised prescribing information for Botox/Botox Cosmetic and Myobloc 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.

Additional information for Healthcare Professionals is provided here. (Information for Healthcare Professionals: OnabotulinumtoxinA (marketed as Botox/Botox Cosmetic), AbobotulinumtoxinA (marketed as Dysport) and RimabotulinumtoxinB (marketed as Myobloc))

The information in this Update reflects FDA’s approval of the revised prescribing information, REMS, and new established names for the botulinum toxin products based on the analyses described in our previous communications about the safety of these products.  For more information on our prior communications see links below.

The FDA urges both healthcare professionals and patients to report side effects from the use of botulinum toxin products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

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