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FDA Warning about Botox for Children with CP   Message List  
Reply | Forward Message #1912 of 2355 |
Re: FDA Warning about Botox for Children with CP

Miralax isn't approved for children either. There are lots of things
used off-label. And every medicine has it's risks -- children have
even died from Reye's syndrome from taking aspirin.

It's all risk management -- does the outcome outweigh the risk?

Personally I find these articles to be very vague.
--- In cerebralpalsy@yahoogroups.com, "access2narnia"
<access2narnia@...> wrote:
>
> Just saw this on CNN and found the article on Yahoo News!
>
> Very frightening!!! I had no idea the FDA had NOT even approved
the
> drug for use with children with CP, although Shriner's Hospital had
> advised us against it for our son because the benefits were not
> permanent, the bracing/casting required would make him more rather
> than less disabled for periods of time, and because they said the
> degree of improvement possible would diminish over time....we
decided
> against it ourselves for these reasons, but have always wondered as
> so many MDs are using it.....
>
> FDA: Children treated with Botox died
> By LAURAN NEERGAARD, AP Medical Writer 55 minutes ago
> The popular anti-wrinkle drug Botox and a competitor Myobloc have
> been linked to some deaths and other severe side effects suggestive
> of botulism, the government warned doctors Friday.
> The drugs use botulinum toxin, which blocks nerve impulses to
> muscles, causing them to relax.
> But in rare cases, the toxin may have spread beyond the injection
> site to other parts of the body, resulting in such problems as
> paralysis of respiratory muscles and difficulty swallowing, the
Food
> and Drug Administration said.
> The FDA said the deaths were all among child patients, mostly those
> with cerebral palsy treated for limb spasms, a condition the FDA
has
> never formally approved for the drugs' use in this country although
> other countries have.
> The problems may be caused by overdoses of the drugs, the FDA said.
> Caroline Van Hove, a spokeswoman for Botox maker Allergan Inc.,
said
> children with cerebral palsy have far larger doses injected into
> their leg muscles than the doses given adults seeking wrinkle care.
> But the FDA warned that it also has reports of side effects in
people
> of all ages given the drugs for a variety of conditions.
> Friday's warning came two weeks after the consumer advocacy group
> Public Citizen petitioned the FDA to strengthen warnings to users
of
> Botox and Myobloc — citing 180 reports of U.S. patients suffering
> fluid in the lungs, difficulty swallowing or pneumonia, including
16
> deaths.
> It is not the first warning about the potential for botulinum toxin
> to spread after the drugs' injection; the products' labels say it
can
> happen.
> Still, the FDA said Friday that its investigation into the side
> effects is still in its early stages.
> For now, the agency said doctors should warn all patients receiving
a
> botulinum toxin injection, whether for cosmetic purposes or as a
> medical treatment, to seek immediate care if they experience
> difficulty swallowing or breathing, slurred speech or muscle
weakness.
> That falls short of Public Citizen's request that the agency put a
> black-box warning, the FDA's sternest, on the drugs' labels and
> require that every patient receive a pamphlet outlining the risk
> before every injection.
> "Every doctor needs to notified about this, every patient needs to
be
> notified," said Public Citizen's Dr. Sidney Wolfe. "Children are
> showing the way, unfortunately some dead children."
> He said drug regulators in Britain and Germany last year required
> sterner warnings be sent to every doctor in those countries.
>





Sat Feb 9, 2008 8:38 pm

my_special_son2
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Message #1912 of 2355 |
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Just saw this on CNN and found the article on Yahoo News! Very frightening!!! I had no idea the FDA had NOT even approved the drug for use with children with...
access2narnia
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Feb 8, 2008
11:34 pm

Miralax isn't approved for children either. There are lots of things used off-label. And every medicine has it's risks -- children have even died from Reye's...
my_special_son2
Offline Send Email
Feb 9, 2008
8:38 pm

I agree to a point that there is risk in most everything we do for our kids-but this one is a very plain issue-and for us, even more plain than it has been...
miriam weir
mweir2
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Feb 9, 2008
8:50 pm
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