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.
More Information on Botulinum Toxin (Botox, Myobloc)
- Statement: FDA Grants Public Citizen's Petition on Botulinum Toxin (Botox, Myobloc), April 30, 2009
- Statement: A Sad Day: Olympians Tout Botulinum Toxin (Botox, Myobloc), July 15, 2008
- Statement: FDA's Botulinum Toxin (Botox, Myobloc) Warning Falls Short, February 8, 2008
- Petition Requesting Regulatory Action Concerning the Spread of Botulinum Toxin (Botox, Myobloc) to Other Parts of the Body, January 23, 2008
- Letter in the Washington Post on "Botox Night" at Johns Hopkins, August 13, 2002
- Letter Requesting Ban on the Demonstration of Medical Interventions, July 12, 2002
- Letter Urging the Cancellation of "Botox Night", July 9, 2002
- Statement on Petition to Repeal DOD/FDA Regulation, May 7, 1996