AP Medical Writer
WASHINGTON (AP) - The popular anti-wrinkle drug Botox and a
competitor have been linked to dangerous botulism symptoms in some
users, cases so bad that a few children given the drugs for muscle
spasms have died, the government warned Friday.
The Food and Drug Administration's warning includes both Botox,
a wrinkle-specific version called Botox Cosmetic, and its
competitor, Myobloc, drugs that all use botulinum toxin to block
nerve impulses, causing them to relax.
In rare cases, the toxin can spread beyond the injection site to
other parts of the body, paralyzing or weakening the muscles used
for breathing and swallowing, a potentially fatal side effect, the
Botox is best known for minimizing wrinkles by paralyzing facial
muscles - but botulinum toxin also is widely used for a variety of
muscle-spasm conditions, such as cervical dystonia or severe neck
The FDA said the deaths it is investigating so far all involve
children, mostly cerebral palsy patients being treated for
spasticity in their legs. The FDA has never formally approved that
use for the drugs, but some other countries have.
However, the FDA warned that it also is probing reports of
illnesses in people of all ages who used the drugs for a variety of
conditions, including at least one hospitalization of a woman given
Botox for forehead wrinkles.
The FDA wouldn't say exactly how many reports it is probing.
"We're not talking hundreds. It's a relative handful," said
Dr. Russell Katz, FDA's neurology chief.
But the agency warned that patients receiving a botulinum toxin
injection for any reason - cosmetic or medical - should be told to
seek immediate care if they suffer symptoms of botulism, including:
difficulty swallowing or breathing, slurred speech, muscle
weakness, or difficulty holding up their head.
"I think people should be aware there's a potential for this to
happen," Katz said. "People should be on the lookout for it."
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.
Nor is it the first warning. The drugs' labels do warn about the
potential for botulinum toxin to spread beyond the injection site
and occasionally kill, but the warnings link that side effect to
patients with certain neuromuscular diseases, such as myasthenia
That's what's different about these latest cases, said FDA's
Katz: The botulism toxin seems to be harming people who don't have
that particular risk factor. (Cerebral palsy involves a brain
injury, not a disease.)
Still, the FDA cautioned that its investigation is in the early
stages. It has asked Botox maker Allergan Inc. and Myobloc maker
Solstice Neurosciences Inc. to provide additional safety records.
Allergan spokeswoman Caroline Van Hove said children with
cerebral palsy receive far larger doses injected into their leg
muscles than the doses given adults seeking wrinkle care.
In a statement, Solstice said it supports FDA's probe but
stressed that the agency hasn't concluded the drug poses any new
While the FDA said the problems may be related to overdoses, it
also has reports of side effects with a variety of doses.
Public Citizen's Dr. Sidney Wolfe criticized FDA's warning as
falling short. He asked that the agency order a black-box warning,
the FDA's strongest type, be put on the drugs' labels and require
that every patient receive a pamphlet outlining the risk before
"Every doctor needs to notified about this, every patient needs
to be notified," Wolfe said. "Children are showing the way,
unfortunately some dead children."
He said drug regulators in Britain and Germany last year
required that sterner warnings be sent to every doctor in those
On the Net:
Top Stories in Consumer
FDA warns of deaths in children treated with Botox
To submit a comment on this article, your email address is required. We respect your privacy and your email will not be visible to others nor will it be added to any email lists.