Botox for Cerebral Palsy Recommended Despite FDA Warnings
A panel of neurologists is recommending that Botox be used to treat some symptoms of spasticity associated with cerebral palsy, despite prior FDA warnings about the possible risk of serious and life-threatening reactions that have already killed several children who were given the injections off-label to treat the disability.
In an article published in the medical journal Neurology, a panel of experts from the American Academy of Neurology (AAN) published a review of several medications that could potentially be used to treat symptoms cerebral palsy. The article includes recommendations that Botulinum toxin type A, known by the brand name Botox, be used to treat spastic cerebral palsy, which is associated with difficulty moving, or stiff and jerky movements.
Botox, manufactured by Allergan Inc., contains extremely minute quantities of Botulinum Toxin A, which causes muscle paralysis. Although the medication is most commonly known for its cosmetic uses to remove wrinkles, it is also approved treat cervical dystonia, spasms of the eyelids and symptoms of severe underarm sweating. While some other countries, including Canada, have approved Botox for cerebral palsy, the FDA has not granted such approval in the United States.
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Learn MoreIn February 2008, the FDA issued a public health warning about potential Botox side effects when the medication is used to reduce spasticity among children with cerebral palsy. The agency indicated at that time that the medication had caused a number of hospitalizations and deaths due to paralysis, most frequently among children with cerebral palsy who are typically given a significantly larger dose of the medication.
A Botox “black box” warning was ordered in April 2009, indicating that side effects of Botox could cause potentially life-threatening problems similar to botulism if the medication spreads from the area of the injection to other parts of the body.
The recent recommendations by the American Academy of Neurology refer to FDA’s warning as “isolated cases of generalized weakness resulting in poor outcomes.”
“For children with CP, (Botox) is established as an effective treatment to reduce spasticity in the upper and lower extremities, but there is conflicting evidence regarding functional improvement,” the panel concluded. “The available evidence suggests that (Botox) is generally safe in children with CP. However, severe generalized weakness may occur.”
Allergan Inc. currently faces at least 15 Botox lawsuits that claim that the company hid the risks associated with the drug. Jury selection began this week in the first Botox trial, involving a case brought by the parents of 7-year-old Kristen Spears, a child with cerebral palsy that died in November 2007 after receiving seven shots of Botox. Allergan has argued that the girl’s death was unrelated to her Botox treatments and failed in an attempt to have the lawsuit dismissed late last year.
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4 Comments
YvetteJanuary 14, 2011 at 5:41 am
My daughter had her 1st botox shot at 4 and it did wonders, I tried it again when she was 12 it works, but the down fall is when it wers off. I am interested in trying the Baclofen pill. My daughter is now 13. Can any give me some first hand advise about the Baclofen pill not the pump.
RachaelFebruary 3, 2010 at 4:03 am
My 2 year old son Patrick has CP and takes 60mg of Baclofen a day as well as 1mg of Diazepam twice a day in conjunction with his Botox injections. I have seen nothing but PROGRESS. Prior to the Botox, my little boy wouldn't even attempt to pull himself up to the standing position or climb stairs. Prior to the Botox he only had the ability to " Army Crawl " now he is a quad crawler who cant wait to[Show More]My 2 year old son Patrick has CP and takes 60mg of Baclofen a day as well as 1mg of Diazepam twice a day in conjunction with his Botox injections. I have seen nothing but PROGRESS. Prior to the Botox, my little boy wouldn't even attempt to pull himself up to the standing position or climb stairs. Prior to the Botox he only had the ability to " Army Crawl " now he is a quad crawler who cant wait to get those two little feet of his in motion. Just last week, his PT brought over a Rifton Gate Trainer to see if my son would show interest and to see if he would benefit from it.......Well my fellow parents, PATRICK WAS WALKING! In fact, he was walking so fast it almost seemed as if he were running. The first thing out of my mouth was "Oh My God His Legs Work" it was the best thing I could have seen yet. It is so wonderful to see Patrick Pulling himself up onto just about everything he can get his hands on. So, for all you fellow parents out there with children with CP,Please keep an open mind when the talk of Botox comes up. Take it from a mom who has seen First Hand the POSITIVE EFFECT of Botox Injections.
BeelenJanuary 31, 2010 at 8:13 am
I find this artical very interesting because there are decate i mentioned many time that they are much more sides effects that one can read in the litterature. in fact first i would say that botox injection is the most simpliest injection one may do, but most of the time done in inapropriate diagnosis and functional issues. often iam shock to discover that most of rehab doc do not know whats spati[Show More]I find this artical very interesting because there are decate i mentioned many time that they are much more sides effects that one can read in the litterature. in fact first i would say that botox injection is the most simpliest injection one may do, but most of the time done in inapropriate diagnosis and functional issues. often iam shock to discover that most of rehab doc do not know whats spaticity is. for them what ever is hypertone is spasticity? amasing also the little knowledge they have over the changing face of Cerebral palsy most of them are lacking sustained postural control have weakness of muscles, the effects of botox mostly is done without selective muscle injections which is impossible without nascosis. the second side effects are multiple, nervous breakdown, apathia, muscles weaknes, atrophy, dribbling, more compensation eslwhere, resignation of the child, more stiffness later on, liever problems with iliopsoas tension, even psychosis.... i really believe that thos injections should be done by specialist who knows how to assess thos kids and which can pretict functional issue in working in a team work, In the philippines and europe, italy, most of injection are done without gait analysis and far away of common sense.
alisonJanuary 29, 2010 at 11:30 am
my son who has cp was given botox the doctor told me he would have a good chance to walk aided but he never did and is now worse than he was before