In a post late last month, I shared Public Citizen recently requested the U.S. Food and Drug Administration (FDA) place a black box warning on Allergan Inc.'s Botox (botulinum toxin type A) and Solstice Neuroscience Inc.'s Myobloc (botulinum toxin type B). Adverse reactions, some serious and even fatal, were related to botulinum toxins spreading beyond the injection site to other parts of the body. This can cause muscle weakness, swallowing problems and aspiration pneumonia. Four of the 16 fatalities involved children under 18 years of age.

Now the FDA has placed Botox under review. Deaths being investigated by the FDA involve children, mostly administered high doses for spasticity in their limbs due to cerebral palsy, an unapproved use of the product. The FDA stated the adverse reactions could be related to overdosing. For example, a dose to treat a leg spasm could be 300 to 600 units, while a de-wrinkling facial injection is commonly 20 to 25 units.

Some doctors say this suggests there is less reason to worry about cosmetic use of the product. However, worried Botox-users should know the FDA is also investigating other reports of illnesses in people of varying ages using the product for a variety of conditions -- at least one woman was hospitalized after a wrinkle-reducing forehead injection. Beyond a black box warning, Public Citizen is also requesting prescribing doctors receive a warning letter highlighting potential complications and consumers receive a guide explaining the risks. Read the FDA's February 8, 2008 press release on Botox adverse reactions here.