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FDA requires “Black Box” warning for Botox, Myobloc and Dysport


The FDA has announced that it will require a “Black Box” warning on Botox and its competitors due to serious adverse side-effects.  Many of the side-effects have been reported when Botox has been used as an off-label treatment for children with cerebral palsy.  Side-effects in children have included difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression.  Serious case reports described hospitalizations involving ventilatory support and reports of death.  The majority of the adult postmarketing case reports occurred following use of botulinum toxin for the treatment of spasticity (an unapproved use) or cervical dystonia.  Some cases resulted in hospitalization, including several cases that required placement of a gastric tube or mechanical ventilation.

About Michael J. Evans

Michael J. Evans is a personal injury lawyer who represents people with claims involving defective medicine or medical devices, other defective products that cause serious injury or death, and environmental cases. Evans also handles whistleblower lawsuits in which employees, or former employees, expose fraud or other illegal conduct by the corporation for which they work(ed), Evans organizes litigation groups of plaintiffs law firms to work with him on these cases nationwide. Evans uses social media, blogs, online video, mobile apps and traditional media to connect with clients, and help other prominent law firms connect with clients.. Evans is also an advocate for the rights of consumers. His primary areas of legal practice are mass torts, and advising law firms on the ethical rules and law governing legal marketing via the Internet and social media.

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