Federal regulators have ordered that botulinum toxin injections, including Botox, Botox Cosmetic and Myobloc, bear a new black box warning regarding their risk of potentially life-threatening complication when the effects of the toxin spread far beyond the injection site. The black box, the Food & Drug Administration’s (FDA) most serious safety warning, will also apply to Dysport, a new botulinum injection treatment just approved by the agency 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. (more…)
