Botox: Stronger FDA Warnings and New Competition

The FDA has issued new, stronger warnings as a result of its February 2008 safety review on the risks of adverse effects associated with Botox injections. Specifically, Botox labels will be updated and providers required to provide further information to patients about the potential for botulinum toxins to spread beyond the site of the injection. The FDA wants consumers to understand that when the toxin spreads, it can cause cases of botulism, a potentially fatal illness that weakens muscles, including the heart.

The greatest risk has been shown with the high doses of the drug used by some doctors to treat cervical dystonia and limb spasms caused by cerebral palsy. Still, there is some risk to patients receiving injections for cosmetic purposes. Inerestingly, some research suggests that higher doses also increase the likelihood of a patient developing a resistance to the effects Botox (presumabley, both benefical and negative effects). See "Are You Immune to Botox?"

It is likely that the new warnings have been spurred by the fact that there's a new kid on the block. A new form of botulinum toxin has just received FDA clearance to be marketed for cosmetic use under the name Dysport. It is manufactured by Ipsen SA and Medicis Pharmaceutical Corp., and is expected to be sold for about 15% less than Botox. In today's economy, it is estimated this pricing strategy could earn Dysport a healthy share of the toxin-based cosmetic injection market.

If you experience a serious adverse event after receiving Botox injections, you are encouraged to report it to FDA MedWatch at: www.fda.gov/medwatch/report.htm