The findings of a new study provide support that Botox may help temporarily relieve moderate to severe drooling problems in children suffering from cerebral palsy (CP) and other neurological problems. However, side effects of Botox to treat cerebral palsy have previously been associated with a number of severe and fatal injuries when the injection spreads to other parts of the body.
The study is published in this month’s issue of the Archives of Otolonaryngology – Head & Neck Surgery, by European researchers headed by Dr. Arthur Scheffer of Radboud University Medical Center in Nijmegen, the Netherlands.
Researchers performed a clinical trial on 131 children who were diagnosed as having cerebral palsy or other nonprogressive neurological disorders. They found that giving them Botox injections resulted in a significant reduction in drooling in 46.6% of the children. The effects of the shot lasted for an average of 22 weeks.
Botox is approved for both cosmetic use to reduce the appearance of wrinkles in the skin and to treat medical conditions such as strabismus (crossed eyes), hyperhidrosis (excess sweating), cervical dystonia (involuntary contractions of the neck muscles) and blepharospasms (involuntary blinking of the eye). However, it also commonly used off-label at high doses to treat stiff and jerky movements associated with cerebral palsy in children.
Minute quantities of Botulinum Toxin A are contained in Botox, which is the bacteria associated with the muscle paralyzing condition Botulism. A number of adverse event reports have been associated with Botox side effects, where the medication spreads from the area of the injection to other parts of the body. These Botox problems have most commonly been seen among children with cerebral palsy, where the typical Botox dose is substantially larger.
Cerebral palsy is caused by an injury to the infant’s brain that can occur before, during or shortly after birth. If the brain of a baby is deprived of oxygen, it can result in irreversible damage that leaves the child with developmental problems, loss of motor functions and other life-long injuries and disabilities associated with cerebral palsy. Symptoms of cerebral palsy are commonly associated with seizures, sensory impairments and cognitive limitation, and can range from mild cerebral palsy to a severe disability.
In February 2008, the FDA issued a warning about the risks associated with use of Botox to treat cerebral palsy, after receiving a number of adverse event reports involving sudden death, breathing problems and other potentially life-threatening injuries. A “black box” Botox warning was added to the medication in August 2009, warning about the risk of botulism-like side effects, such as swallowing and breathing difficulties, that can occur if the injection spreads to other areas of the body.
There are currently a number of Botox lawsuits pending against Allergan that allege the drug maker illegally promoted the medication for non-approved uses and failed to adequately warn about the risk of these severe and potentially life-threatening Botox injuries.
Sunday, September 26, 2010
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Posted by BA Haller at 10:29 AM