Botox® is a popular, anti-wrinkle drug derived from a sterilized form of botulinium toxin. The well-known drug works by temporarily paralyzing and impeding muscle movement. Allergan Inc., the manufacturer of Botox®, has been seeking Food and Drug Administration approval for use in controlling muscle rigidity and spasticity in stroke patients. The drug has also been used for years, without FDA approval, in reducing muscle spasticity for children with Cerebral Palsy.

If you or your child has received a Botox® injection anywhere in the United States and suffered from a severe side effect, then contact the Botox® injury and malpractice attorneys at Schlichter, Bogard & Denton. Our pharmaceutical litigation attorneys can offer insightful analysis of your claim against the manufacturer of Botox® and/or the physicians that prescribed the treatment.

Reported Botox® Side Effects with Off-Label Use

On May 14, 2009, the FDA issued additional warnings about Botox®, Botox® Cosmetic and Myobloc, after some children died or suffered severe injuries when the drug spread away from the injection site. Federal drug authorities stated that Botox® was never approved for use in pediatric patients. Nor was it approved in the doses required to affect spastic muscles. If administered to these groups of patients, adverse reactions can cause botulism-like symptoms that include:

• Difficulty breathing
• Difficulty swallowing
• Muscular weakness
• Facial and eyelid dropping
• Aspiration pneumonia
• Speech disorders
• Double vision
• Respiratory distress, and even death

After additional reports surfaced from women who received anti-wrinkle drug injections while pregnant and subsequently gave birth to children with birth defects, the FDA began requiring the manufacturer include a Black Box warning about adverse side events when the drug migrates from the initial injection site. The FDA also then requested that all side effects be reported through MedWatch.

FDA-Approved Botox® Product Uses

Botulism toxin is injected under the skin or into the muscle tissue and has only been approved by the FDA in one or more of the following uses:

• Temporary improvement in the appearance of frown lines between the eyebrows
• Treatment of strabismus (crossed eyes)
• Treatment for abnormal eyelid tics and twitches
• Treatment for involuntary sustained or repetitive contraction of neck muscles
• Treatment for severe underarm sweating
• Treatment for migraines

Filing Your Botox® Claim

The personal injury attorneys from Schlichter, Bogard & Denton are well-known for their drug recall litigation and lawsuits on behalf of those harmed by pharmaceutical drugs like Botox®. If you or your child has experienced an adverse reaction after receiving an injection for anti-wrinkle reduction or another off-label use, contact our attorneys for a private, no-cost consultation to discuss your case.