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Medical News & Perspectives
June 10, 2009

FDA Requires Black Box Warnings on Labeling for Botulinum Toxin Products

JAMA. 2009;301(22):2316. doi:10.1001/jama.2009.780

The US Food and Drug Administration (FDA) is requiring manufacturers to label botulinum toxin products with black box warnings about the possible risk of botulismlike symptoms associated with systemic spread of the toxin.

The FDA is also requiring Allergan Inc, which sells Botox and Botox Cosmetic (botulinum toxin type A); Solstice Neurosciences Inc, which sells Myobloc (botulinum toxin type B); and Ipsen Biopharm Ltd, maker of the recently FDA-approved Dysport (abobotulinumtoxinA), to develop risk-management strategies plans to prevent such adverse events. Additionally, the agency is requiring clinicians to provide a medication guide outlining botulismlike risks to patients treated with the drug or to their caregivers.

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