FDA Drug Safety Communication

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, including:

- 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.

View the full FDA Drug Safety Communication on FDA.gov