> -----Original Message-----
> From: [log in to unmask]
> [mailto:[log in to unmask]]On
> Behalf Of Joan Francis
> Sent: Friday, February 08, 2008 2:29 PM
> To: [log in to unmask];
> [log in to unmask];
> [log in to unmask]; Andrea
> Roberts; Darryl &
> Margaret Brown;
> [log in to unmask];
> [log in to unmask];
> [log in to unmask]
> Subject: SCE FDA Warning About Botox Deaths in
> Children
>
>
> 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.
>
>
>
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