Botox injections, which are commonly used for cosmetic procedures or “off-label” to treat conditions such cerebral palsy, have been associated with severe and potentially fatal reactions.
STATUS OF BOTOX LITIGATION: At least one Botox lawsuit has been filed on behalf of 15 individuals who suffered severe or fatal injuries after receiving the injection. Lawyers are investigating potential cases throughout the United States.
MANUFACTURER: Allergan, Inc.
OVERVIEW: Botox contains small quantities of Botulinum Toxin A, which is the bacteria associated with the development Botulism, a muscle paralyzing condition. The medication is approved for cosmetic reasons, as well as to treat strabismus (crossed eyes), hyperhidrosis (excess sweating), cervical dystonia (involuntary contractions of the neck muscles) and blepharospasm (involuntary blinking of the eye).
Botox injections are used for for cosmetic purposes to help reduce the occurrence of wrinkles in the skin by stopping muscle movement, particularly around the eyes, nose and mouth.
There are also a number of off-label uses of Botox. The most common off-label use is for the treatment of children with cerebral palsy, which can be associated with stiff, jerky and difficult movements caused by muscles that are in a constant state of tension. Use of Botox to treat cerebral palsy symptoms can be effective, as the toxin binds to the nerve endings, preventing the muscles from contracting.
BOTOX SIDE EFFECTS: In February 2009, the FDA issued a public health warning to consumers and healthcare providers following a number of reports of deaths, breathing problems and other adverse reactions associated with the use of Botox. The FDA indicated that the adverse reactions were most commonly seen among children with cerebral palsy, where the typical dose of the Botox injection used is substantially larger than what is normally prescribed for cosmetic purposes.
When given in large doses, the side effects of Botox could produce symptoms similar to Botulism, which is a serious and potentially life-threatening disease. Symptoms could include:
- Double or Blurred Vision
- Drooping Eyelids
- Slurred Speech
- Dry Mouth
- Difficulty Swallowing
- Respiratory Distress
The consumer advocacy group Public Citizen has called for stronger warnings about the potential Botox side effects, which they have asked the FDA to include in a “black box” warning on the label, which is the strongest possible warning that can be placed on a prescription drug.