More than a year after beginning a safety review, the Food & Drug Administration (FDA) announced today that labels on Botox and similar products will bear its strictest safety warning. The agency said today that the warning, known as a “black box”, will include information on the risk of adverse events when the effects of a botulinum toxin injection spreads beyond the site where it was injected.
The new black warning will apply to several products. Botox, which is made with botulinum toxin type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. A third product, Myobloc, is made from botulinum toxin Type B and is approved for the treatment of adults with cervical dystonia. The new black box warning will also apply to Dysport, a botulinum toxin product that was just approved for use in the U.S. by the FDA today.
Last February, the FDA launched a safety review of botulinum toxin injections, including Botox and Botox Cosmetic. The FDA said at the time that it had received reports of adverse reactions that resembled botulism infections in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may have been due to overdosing.
In addition to the new black box warning, the FDA said today that it will require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including 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. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers.
The FDA also said today that it is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.
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