FDA warns of Botox side effects

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FDA warns of Botox side effects, deaths

http://www.cnn.com/2008/HEALTH/02/08/botox.warning.ap/index.html

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.

Botox contains botulinum toxin, which blocks nerve impulses to

muscles, causing them to relax.

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.

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 neuromuscular diseases.

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

risk factor of a neuromuscular disease.

Still, the FDA cautioned that its investigation is in 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 inquiry 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.