Saturday, October 3, 2009

Botox Indeed

Allergan, maker of Botox, is involved in a little bit of a role reversal in regards the practice of off label use of its product. (off label is a used not approved by the FDA, but legal – as long as the drug maker does not market the drug for said off label use)

Most people have heard of Botox and know that it is used for a wrinkle treatment (scary as that is). The FDA has approved Botox for other conditions as well and these include eye twitching and being cross eyed, muscle spasms in the head and neck area and profuse sweating.

Botox is made from a bacteria and it is toxic even in small doses. It is used as a medicine however in even smaller doses. It is not without risk, in fact, the FDA just this year ordered not only a label change but specific education to physician’s about dosing and that though there are four marketed products, the dosing of each is DIFFERENT and that needs to be clearly explained to prescribing clinicians.

The odd twist is that after the FDA made this “order” to Allergan, Allergan sued them in order to be able to market the product to doctors for off label use! They feel that they need to tell the physicians how to use the product for other conditions so that off label use will be safe and effective. Well, if they KNOW that stuff, they must have some clinical data, some trials they completed , so why not apply to the FDA for the new uses!

I am confused though because the fuss seems to be over using the medicine or toxin, for treating muscle spasm. It is approved for cervical dystonia which is a muscle spasm condition, but of the head and neck area. I know that one use Allergan wants to market and explain is for muscle spasms in kids. On the Internet, I found reference to off label uses for neck and back pain as well as migraines.

Lord heaven, I cannot imagine any condition that would lead me to have botulinum toxin injected into my body. And if you detect bias in my post today, well you have very good comprehension skills!

No comments: