Botox Warning Issued by Food and Drug Administration

February 9, 2008 Kyron 2 Comments

The FDA released a communication on Friday regarding the use of Botox, Botox Cosmetic  (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). They have received reports where there have been adverse reactions including significant respiratory problems and even death. This release specifically mentions that most of the serious reactions that have happened are in children where the botulinum is being used to treat cerebral palsy associated limb spasticity.

Obviously this announcement has been winding it’s way through the disability community. It’s of critical importance that the message get out there and it’s why I am making it the subject of my post today.

First of all, while it is critical that this information get out there please note that the FDA has not yet concluded that the relationship is anything more than “casual” at this point. Basically this means that while the adverse reactions happened and the individuals had Botulinum treatments they aren’t sure what exactly caused these individuals to have the adverse reaction while others did not.

They also are not telling healthcare professionals not to continue prescribing or using these products. As they say in their statement

“The FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action.”

Meaning they don’t know whether they are going to regulate the use of these products differently than they currently do. They do however remind people that the use of these toxins for the treatment of limb spasticity (severe arm and leg muscle spasms) is not an approved use in the US.

Plenty of medications are used “off label” . Some of the best medications for certain diseases started off in an “off label” use. The reality is that many medications that children take for a variety of illnesses and disabilities are off-label because so many of these medications have not been tested in children under the age of 18.

The important thing is that you be an informed consumer. In using any treatment or medication you need to know what the pros and cons are. You need to know what the possible side effects are. Obviously the serious outcomes that the FDA is reporting are worth evaluating with your physician if this is a treatment either you or your child is using. As with any treatment weighing the benefits against the possible adverse effects is something you and the doctor must do and each situation is different.

If you are using this treatment make sure to go to this link, print the page out and go to your doctor with it. At the very least, if you are going to continue utilizing this treatment, make sure you understand warning signs and symptoms and you don’t hesitate to seek out medical attention if there are signs of difficulty swallowing or talking, trouble breathing or muscle weakness. These symptoms can show up either hours, days or weeks after the treatment so don’t think they aren’t related just because they show up weeks later – It could still be the botulinum.

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Categories : Diagnoses, Medical, News

Currently there are "2 comments" on this Article:

  1. Deana says:

    This sure has been making the rounds in our community of kids with organic acidemias.

    The thing to remember is each day we as parents of special needs kids have to make great decisions for our kids, and sometimes those are looked upon by outsiders as something that could harm them. Max is on a medication that can not be sold in the US because it is not FDA approved. That medicine saved his life and has kept him seizure free for over 2 years. Each child, each family, each situation is different. That’s why we must be educated on your child and their set of circumstances.

  2. Kyron says:

    Deana,

    You got it! Each situation is different and yours is the perfect example. Each of us can only make the best decision we can at the time with the information we’re presented. Education and information are key.

    ~Kyron

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