2009
  • FDA approves the following revisions to the prescribing information for 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.

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