What do you think about the new release of news on CNN on the warning of Botox? I invite any comments.
FDA warns of Botox side effects
FDA: Botox and a competitor linked to severe side effects, deaths
Botulism toxin may spread through body, resulting in respiratory paralysis
Deaths were all children, mostly those with cerebral palsy treated for limb spasms
FDA: Docs should warn all patients who get botulinum toxin injections
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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.
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.
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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 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.
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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

I think the thing is, there are risks associated with any medical proceedure. We would really need more hard facts and statistics to make a fair analysis. (ie accurate percentages )
Of course with any proceedure you have to weigh up the potential benrfit versus the potential adverse effects.

The most serious of the reported problems occurred in children who had cerebral palsy and who were treated for arm and leg spasms with doses many times those used for cosmetic treatments -- and in some cases at levels higher than recommended guidelines. The agency did not identify which drugs were involved in any of the problems.
LA Times
http://www.latimes.com/business/printedition/la-fi-botox9feb09,0,617768.story
There is no need for a botox scare, at least not yet.
These findings come from one group receiving extra-large doses of the botulin. Here is a link to the FDA's website and early recommendations:
http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm

Every procedure comes with risks. I wouldn't let that report stop me from getting botox if I thought if would improve my quality of life.

I don't know what to say. I just know that I decided not to have Botox after I read the disclaimer. It stated among other things that there were cases of death and since CRSs still are experimenting with different doses and don't even have one universal protocol for administration of the drug - I decided to "pass" the offer. It was not attractive to me also because of high fissure recurrence rate - I just wanted to be "fixed" forever if I am taking any risk. So, yeah..we all must read the small print and we all have to make decision on individual bases.

There isn't a SINGLE drug that hasn't caused a small group of people considerable harm. Read the side effects for Aleve, Advil, or Tylenol and they would appear to be far more dangerous then Botox, yet millions of people take them everyday...and for prolonged periods of time. At my last CRS visit, the doctor told me to take 3 Advil 3 times a day for 2 weeks for fissure pain.
But excellent job bring up the article Benard. Thanks!

Chris
I agree with you. The doctors i have seen dont really recommend Botox and i just think its because they dont see a high success rate with it. I need to get the surgery but I have IBS which puts me in a high risk catagory for the surgery. Both doctors said i would have a tempory incontence issue due to IBS. Again this is just their take and not mine. I am not really worried about the reactions stated in the article. Just me wearing a diaper for a couple of weeks does if it does happen.
Just weighing out the options. You know how the news is it spokes people out including me when you see things like this.
The only thing my doctors brought up about it is other reactions not mentioned in the article like alergic reations and stuff like that.
They did recommend the botox for a first approach.
Thanks for your comments
Bernard

Benard,
Being a person who was going to have he surgery (was put under and ready to go, but the doctor woke me up and said that my sphinchter muscle was just fine) and then getting my first round of botox, in hind sight I would have gone with the botox first.
Most of the articles I read on Pubmed give botox a very high rate of healing. If not the first round, then usually a second round does the trick. And the best thing is, the side effects are reversible. I found that out of the three CRSs that I saw, it was only the younger one that was willing to do the shots. I think the shots are too "new school" for some of these CRSs. I also find that more GI doctors will do the shots as well.
Whatever you decide, go luck and thanks again for the info!

thanks chris

Good luck Bernard with whatever procedure you decide to have !
Why your doctor thinks that you will have problem with continence if you have IBS ??? I had LIS and had loose stool couple of times so far and had no problems with continence whatsoever !
Regarding Botox - I met 4 CRSs and 2 did procedure , 2 did not. One of those who did was about to retire, and other one was about 45 years old - so I think that age has no correlation with that. Some CRSs just like to try innovative procedures, some like to stick with what they know the best and also some are involved in studies and are collecting data.
All the best and take care of yourself on your trip ! : )