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http://www.foxnews.com/wires/2008Feb11/0,4670,BotoxWarning,00.html
FDA Links Anti-Wrinkle Drugs to Deaths
Monday, February 11, 2008
Also FDA: http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm
WASHINGTON - 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 FDA said.
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 spasms.
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 gravis.
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 risk.
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 each injection.
"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 countries.
FDA Links Anti-Wrinkle Drugs to Deaths
Monday, February 11, 2008
Also FDA: http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm
WASHINGTON - 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 FDA said.
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 spasms.
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 gravis.
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 risk.
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 each injection.
"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 countries.