FDA Warns Of Botox Death Risk

(CBS/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 U.S. 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 would not 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.

"What we're saying is, nobody should be dying of Botox, and they wouldn't be dying if the government and the companies were doing a better job warning people," Wolfe said to CBS Early Show co-anchor Maggie Rodriguez.

[trevormom]

I usually don''t get involved in any type of "chat"... but I do have to say that this touches very close to home and I feel I need to have a say.

I am with mdmitchell67.... I to had done a lot of research regarding botox injections and no, not for the wrinkles that life so nicely adds to our aging process, but for our 8 yr old son Trevor.... he has CP and thanks to botox injections he can now sit at a 90% angle (like most typical people) and can walk using his a walker standing almost fully straight up and down as apposed to having such tight ham strings he was always bent at the knees and had much more diffuclty with his gate. He has had botox injections every 3-4 months for the past 2 years. We had done the research and found after speaking with several md''s; that like any/all medications there are risks involved. (Have you ever read the insert to any of the medication you are perscribed...makes me just want to swallow that pill... anyone one would run scared if they read all the "possible side effects"...... )the dosage needs to be monitored and administered correctly....

Will these article make us stand up and take a better look after each injection and keep a better eye on the possible side effects.... absolutely...

Will it make us stop having our son treated with botox... I don''t really think so.... it really depends on how much you trust your Dr. and we would have to weigh the consequences of NOT having the treatments...

[baileyccc]

What a surprise! Our FDA which approve this toxic substance is now telling us it can harm us. Just like a bad drug that makes 10 of billions of dollars then it is taken off the market. Refunds do not apply. Corruption at the highest level of health care. Big Pharma marchs on with sky high profits. The FDA needs a massive shake up.

[deb82]

I have a traumatic brain injury and have been receiving botox since 2002 for spasticity. I had it to help me walk again. Then in 2005 I hit my head again and I''m back on my walker. I started botox again, however this time around it weakened my entire body and I was choking and have a hard time breathing.
My physiatrist didn''t know anything about this. But after researching my case he found out that it happens but it''s rare. Not sure why it''s all of a sudden happening after so many successful injections. It''s used for several other medical reasons not only cosmetic.

[xlib]

shanev-I forgot to mention Waco and the Elian Gonzalez debacle. Still say queen nance better be careful.

[xlib]

shnev137-I''m not a Bush lover. I just like to point out insanity when I see it. I find it increasinly interesting how bubba got away with everything and anything and the loony left blames Bush for the darndest things. As for Bush "running the FDA into the ground", cite your source. Prove it. I gather from your last paranoid sentence that you grow your own food??
Try taping into reality and you will see that clinton was far from the saint you leemings make him out to be. After all, he is close friends with the chi coms taking millions upon millions and did give us nafta.

[gce65]

Are you kidding? THIS IS NATURAL SELECTION IN A BOTTLE!

[garbosmed]

FDA gives a warning about botox after it affects 180 people total in the whole country. But what about the girls and young women who''ve died from the Gardasil vaccine? Why not put out a warning about that? Or the many many many children who have been vaccine injured and are in the CDC VAERS database? Nope, nothing to see there, just move along. Hello, FDA? WAKE UP!!!

[underdogus]

_______
_______)~~----gun control
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[mdmitchell67]

To exCoachKen,
I do not know the percentage of cases where botox is used for non-cosmetic purposes. That was not part of my research as I was not considering any cosmetic issues, only medical ones. I wonder why 10% was your magic number for issuing an apology. Would you feel any different if it were only 1%? In any case, my concern is that if people can only focus on botox as a cosmetic drug, they will feel free to push the FDA to take it off the market, assuming that only the vain will suffer its loss. Without getting into a political argument (which this issue seems to also be bringing out in these discussions...), I must also say I have concerns with how the FDA makes its decisions, and how easily it might be swayed by public opinion (and, as I have seen here, public opinion is often formed by misconceptions). As we all know, if aspirin were a new drug today, the FDA would never approve it. I am feeling defensive because I fear that a drug that has worked miracles for many children might be banned because of misinformed people.

[excoachken]

To mdmitchell67: Since the rest of us are so"judgmental" and ignorant, please inform us on the % of Botox used in the treatment of Cerebral Palsy as compared to that used for cosmetic purposes and simple vanity. If that used for c.p. is over 10% of the total, you have my humble apology for somehow offending you because I was critical of those who just want wrinkles to go away. But, regardless, since nobody complained about it''s legitimate medical use, why are you so defensive? Again, p[lease tell us what the percentages are?