FDA Warns of Botulism With Unapproved Use of Botox

[babylonsister]

FDA Warns of Botulism With Unapproved Use of Botox

By THE ASSOCIATED PRESS
Published: April 30, 2009

Filed at 6:23 p.m. ET


WASHINGTON (AP) -- Health officials warned doctors and patients Thursday about potentially deadly risks of using the anti-wrinkle drug Botox and similar drugs for unapproved uses to treat certain types of muscle spasms.

The Food and Drug Administration said Botox and two other injections carry risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

While Botox is best known for clearing wrinkles by paralyzing facial muscles, the botulin-based drug also is widely used for muscle-spasm conditions. 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. Signs of botulism can appear just hours after injection and include difficulty swallowing or breathing, slurred speech and muscle weakness.

Manufacturers Allergan, Solstice Neurosciences and Medicis will have to bolster warnings on their products and collect additional safety data. The companies will also be legally required to distribute medication pamphlets about the risks to patients.

The agency began investigating the problems last year at the behest of Public Citizen, a consumer advocacy group.


more...

http://www.nytimes.com/aponline/2009/04/30/business/AP-Botox-Warning-FDA.html

[Berry Cool]

1. I have always wondered whether this was possible.

(And always been reassured "no, no, they use a PURIFIED version of the stuff." Which I never understood, because the whole reason it works on wrinkles is because of what it does that makes it poisonous...it paralyzes muscles...what difference does it make how "purified" it is?)