Botox Cerebral Palsy Problems Lead to Warnings
The FDA announced Monday that a new black box warning labels for Botox and similar products has been approved, warning about the risk of serious and potentially life-threatening botulism-like side effects. The Botox problems, which can include respiratory problems and death, have occurred most commonly in children with cerebral palsy who received injections off-label for treatment of muscle spasticity.
>>PRIOR POST (2/9/2008): Botox Cerebral Palsy Side Effects
The FDA required more stringent warnings and new medication guides for Botox, Botox Cosmetic and Myobloc in April, and announced on August 3 that it approved of the manufacturers’ proposed label changes and guides. The warning alerts users that the effects of botulinum toxin used in the products could spread from the area of injection to other areas of the body, potentially causing botulism-like symptoms including “life-threatening swallowing and breathing difficulties and even death.”
FDA’s April requirement of a black box warning, the strongest possible label warning that the agency can impose on a product, came after the agency received multiple reports of adverse side effects, including deaths, associated with the use of Botox to treat muscle problems, particularly in children with cerebral palsy, for which the product is not approved. Cerebral palsy Botox treatments use much larger doses than cosmetic use of Botox and are applied to areas more likely to allow the toxin to spread to other parts of the body and cause Botox problems.
In addition to the approved new black box warnings and medication guides, the manufacturers will also have to collect safety data on adults and children with muscle spasticity to assess the risk of the spread of the toxin effects. Botox and Botox Cosmetics are manufactured by Allergan, Inc. and Myobloc is manufactured by Solstice Neurosciences.
Symptoms of potential Botox cerebral palsy treatment problems could include:
- Double or Blurred Vision
- Drooping Eyelids
- Slurred Speech
- Dry Mouth
- Difficulty Swallowing
- Respiratory Distress
BOTOX CEREBRAL PALSY LAWYERS
The lawyers at Saiontz & Kirk, P.A. are reviewing potential Botox cerebral palsy lawsuits on behalf of families of children who were given the injection off label and suffered serious or fatal side effects. The manufacturer of Botox has failed to adequately warn about the potential life-threatening problems when used to treat cerebral palsy and appear to have actively marketed the drug for this unapproved and danagerous use.
To review a potential claim for your child or loved one, request a free consultation and claim evaluation.