What should the average consumer make of the recent FDA warning in February about botulinum toxin products, such as BOTOX Cosmetic? At this time, this communique was a warning without any change in prescribing instructions for the products. It noted that there have been some adverse outcomes both in children and adults, with the deaths or serious effects only seen in children. The dose range among adults who had problems, such as weakness in the legs, was 100-700 units. It has not been specified how common these side effects were.

What this means is hard to calibrate since there is no incidence number given. If a million treatments for Botox are given in a year in the U.S. but only handful of cases have some kind of adverse effect, then the chance of the adverse effect is extremely small. Furthermore, the only deaths were in children, and all adults with serious side effects had doses upwards of 100 units. Although 100 units is within the range of a typical Botox treatment, most patients receiving injection for wrinkles receive a lower amount.

For now, we should continue to observe the prescriber cautions and await further notification from the FDA.

This entry was posted on Thursday, May 1st, 2008 at 6:44 am and is filed under BOTOX. You can follow any responses to this entry through the RSS 2.0 feed. Responses are currently closed, but you can trackback from your own site.