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FDA Warning about Botox for Children with CP   Message List  
Reply | Forward Message #1911 of 2353 |
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.




Fri Feb 8, 2008 11:34 pm

access2narnia
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Forward
Message #1911 of 2353 |
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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
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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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