Botulinum Toxin

Brand names: Botox, Myobloc

Hollywood stars are so nonchalant when talking about botulinum toxin (Botox) that you might assume these injections are harmless miracle-treatments (but for the price tag), a modern-day fountain of youth. But the truth is that Botox, approved for use in 1991 for a limited number of therapeutic uses as well as to temporarily improve the look of “frown-lines” (wrinkles between the eyes), can have serious and sometimes life-threatening side effects.

In 2008, Public Citizen petitioned the FDA for a black box warning to be placed on the drug label; an FDA-approved Medication Guide for patients; and a “Dear Doctor” letter, all alerting doctors and patients to the serious problems associated with Botox.

In April 2009, the FDA granted the petition in full, and even went further to require companies to conduct additional studies examining the use of the drug for the treatment of spasticity associated with cerebral palsy, an unapproved use.

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