FDA Issues Strengthened Warnings in Labeling for Botulinum Toxin and Related Products

May 1, 2009

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The US Food and Drug Administration (FDA) has notified health care professionals of a new requirement for manufacturers of licensed botulinum toxin products to strengthen warnings in product labeling. The requirements include the addition of a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected. This warning is the result of an ongoing safety review initiated by the FDA in February 2008.

The FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy (REMS). This entails creation of a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged.

Read the full FDA Press Release, "Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)." (Posted 04/30/2009)