Unapproved Use of Botox Linked to Deaths, Injuries in Cerebral Palsy Patients

Botox, the blockbuster cosmetic drug used by millions of people to turn back the hands of time and reduce the appearance of frown lines and wrinkles, has caused fatal and severe complications in cerebral palsy patients who are injected with the product in unapproved treatments.

Botox and products like it, such as Myobloc and Dysport, use a purified form of botulinum toxin to temporarily paralyze muscles to stop their repetitive movements and prevent wrinkles from forming in the skin. The drugs also are approved by the Food and Drug Administration to treat excessive sweating, crossed eyes, and other conditions.

However, Botox is widely used by physicians for unapproved, “off-label” treatments of muscle spasticity in adults and children with cerebral palsy. In these procedures, extremely high doses of Botox are injected into the bodies of cerebral palsy patients to control the involuntary muscle movements and rigidity associated with the disorder.

These large doses of the drug can quickly migrate inside the body, spreading from the injection site and reaching the lungs and throat, where Botox can interfere with or stop breathing, swallowing, and other vital bodily functions. Some cerebral palsy patients, particularly young children, have been hospitalized or died from botulism after Botox injections spread through their bodies and caused respiratory failure.

The use of Botox or Myobloc for the treatment of muscle spasticity is not approved in the United States for adults or children because the efficacy and risks of the treatment have not been determined.

FDA Warns of Botox Dangers

In April 2009, the FDA ordered the makers of Botox and Myobloc to include on their products’ packaging stronger warnings about the risk of serious injury when the drugs spread through the body. Dysport, another drug like Botox that was recently approved in the U.S., also was told to carry the same warning label.

Previously, the FDA had issued an “Early Communication about an Ongoing Safety Review,” which indicated the agency was launching an investigation into reports of Botox and similar drugs causing systemic adverse reactions, including respiratory failure and death.

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