Mark & Associates, P.C. Attorneys At Law

Botox Linked to Severe Injuries and Deaths, FDA Warns

The Food and Drug Administration has repeatedly warned that the popular drug Botox has been linked to severe injuries and death. Botox is best known as an anti-wrinkle treatment, but the drug also is approved to treat specific neurological conditions and excessive sweating.

Botox is commonly used off-label (non-approved use) for the treatment of muscle spasticity in cerebral palsy patients. In its warning, the FDA said it was aware of literature describing the use of Botox to treat limb spasticity in children and adults, but the safety, efficacy and dosage of the drug have not been established for the treatment of limb spasticity of cerebral palsy or for use in any condition in children less than 12 years of age.

FDA Orders Stronger Botox Warnings

On April 30, 2009, the FDA ordered the makers of Botox and a similar drug, Myobloc, to include stronger warnings on the products’ labeling to advise patients and physicians of the risk of injury when the drugs spread through the body. When Botox migrates from the injection site, it may come into contact with and stop the movement of the muscles which control breathing, swallowing, speaking, and other vital functions. Several children being treated with Botox to stop muscle spasticity associated with cerebral palsy have died due to the spread of Botox.

The FDA’s earlier warning about Botox came in the form of an "Early Communication about an Ongoing Safety Review" which means the agency has just begun to investigate the safety concerns, and will most likely release more information to patients and doctors.

The preliminary warning focused on reports of systemic adverse reactions including respiratory failure and death following the use of Botox and its competitor Myobloc, for both approved and unapproved uses. These reactions appear to be the result of botulism, which occurs when botulinum toxin from Botox or Myobloc spreads in the body beyond the site where it was injected.

The most serious reports of adverse events mostly involved children being treated for cerebral palsy related muscle spasticity, which lead to hospitalization and death. It is important to note that the use of Botox or Myobloc for the treatment of muscle spasticity is not approved n the United States for adults or children.

Free Legal Consultation for Botox Patients

If you or a loved one has suffered from side effects associated with the cosmetic or therapeutic use of Botox or Myobloc, contact our attorneys immediately for a free legal consultation. To request a free consultation submit the contact form on this page or call us at 1-866-50-RIGHTS (1-866-507-4448).