The FDA has approved Botox for cosmetic purposes as well as for serious medical conditions. But after a few complications in children, including deaths, the FDA is reviewing the paralyzing drug.
This review comes out after a few cases were reported where botox was used on seriously ill children.
Neurologist Dr. Dan Silverman said, "It appeared to be the group that was most affected was children with cerebral palsy under the age of 12, and I believe the treatment was for lower extremity problems, and I suspect that the reason may have been is that the larger doses are used to treat lower extremities problems."
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Dr. Silverman uses Botox successfully on many patients who suffer from cerebral palsy and multiple sclerosis.
"The reason we tend to use it is number one to improve function, which could be from using crutches to not using crutches or even getting up from a wheel chair and be able to ambulate with some assistive device so really substantial functionally improvement can be seen," said Dr. Silverman.
Facial Plastic Surgeon Dr. Edwin Williams who uses botox on many clients for cosmetic reasons says the review has not impacted his practice.
He said, "I know it is safe. It has been use in 13 million patients since 2002. Three million patients in 2006. It is the number one most common cosmetic procedure in plastic surgery right now, number one. Kinda like aspirin, it has been used for 18 years."
In early communication, the FDA report indicated the usages for children who had adverse effects ranged from 100 to 700 units and the dosages for the use in cosmetics was much less.
Dr. Williams said, "With the average patient, we typically inject between 10 and 20 or 30 or 40 units, so they are using massive doses when compared to what is used in therapeutic cosmetic botox."
Dr. Williams said not only is much less Botox used, the site of the injections tends to be done in the smaller, facial muscles. The risk of permanent damage is also slim.
Dr. Silverman said, "The fact is that it hugely diluted, the dose is tremendously small and it is diluted to the 100 to thousands and the scale that the amount given is in the nano scale range."
The bottom line, Botox is still FDA approved for both cosmetic and medical use.
Dr. Silverman said, "What they have not done is they have not taken it off the market. They have not created any kind of black box warning at this point and they have not said not to use it. So we find it still to be a very beneficial drug. It is also known for cerebral palsy that is an area that has shown a great deal of benefit and reduced the need for surgical treatment."