Thursday, February 14, 2008

Doctor Responds to Botox Fears

Are any of you moms considering botox or know someone who is? Do you know anyone who has a child with cerebral palsy that is looking into alternative treatments like botox? You might want to read this CNN story about botulism.

At the end of the article, hear what the owner of Soderstrom Dermatology Center in Peoria, Il has to say about the federal warning.

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 warns.

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. 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,

  • 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."

The 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.

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.

Dr. Carl Soderstrom at Soderstrom Dermotology Center in Peoria, Illinois said the current warning for botox for cosmetic use are sufficient, but “in the judgement of the FDA further labeling for Botox use in children with spastic diseases is warranted, it should be done. For cosmetic use I believe the warnings are more than adequate and the current warnings have served us and our patients well. “ He said the treatment of Botox for children with spastic diseases uses much higher doses than those used for cosmetic treatments.

Dr. Soderstrom said he isn't aware of any patients having a negative result from cosemtic botox procedures at his office and he has been offering the wrinkle reducing procedure since it was first available several years ago.

Soderstrom Dermatology Center uses botox for one other reason besides wrinkles: post herpetic pain in some hyperhidrosis patients, or people who has excessive sweating. He said those patients say it's very helpful.

Dr. Soderstrom said both the American Society of Dermatological Surgeons and the American Society of Plastic Surgeons support the current labeling of all Botox® products, and believe that the current data supports the continued safe use of this product with no change in labeling necessary.

Here is a list of the possible side effects of Botox when used for cosmetic reasons:

  • A rare syndrome of migraine headaches
  • Malaise
  • Weight loss and disability, that is unproven, but may be related in unusual circumstances to Botox®;
  • Temporary paralysis of other nearby muscles resulting in temporary loss of function (eg drooping eyelid, difficulty closing the eye);
  • Headache, local numbness, rash and bruising.

-NewsAnchorMom Jen


ross hoffman, md said...

Hello, this is ross hoffman, md. I am a cardiologist and founder of a medical device company, NeuroQuest Therapeutics. I have extensive experience with botox products due to my 14 yo son's need for injections in his legs, for a condition called dystonia.. I have also rec'd botox in my forearm for writer's cramp. The Botox danger is misguided. The FDA is living in medical legal paranoia and we have a fear stricken world which hates drug companies. These issues ultimately are a disservice to pts as innovation is stifled. The problem with botox is that so few physicians are skillful at its administration. This is beyond dispute and well known by patient-users of neuromuscular (rather than cosmetic) botox. It is important that we align our goals and create a culture of innovation and of course safety. The current litigious and risk averse environment hurts us all, except our legal friends. I hope these comments are helpful.
Best wishes, Ross

Anonymous said...

My name is Robin and I suffer from a secondary generalized dystonia that is pretty much thur out my entire body. I had botox injections in my forearm for my writers cramp, the botox traveled to my ulner nerve and into the muscle in the back of my upper arm. For 3 months I suffered excruciating pain from the nerve and the muscle some 4 years later still gives me a lot of pain and discomfort while performing certian tasks. It is my understanding that Botox is not even approved by the FDA for legs and arms nor for childern under the age of 18. I applaud the efforts to strengthen the warnings for Botox. As it is true that many people obtain great relief from the use of Botox, others like myself are not so fortunate. Strengthing the warnings will in no way harm those who do obtain relief however it may help to warn those who experience the types of effects they speak of here and that I experienced. Regards, Robin

Anonymous said...

I have received botox for cosmetic purposes, and have had no ill effects. As with any medical cosmetic procedure there is risk, however as a consumer you must do your homework. Your article was informative, but I'm still getting my botox.

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