Botulinum Toxin
Brand names: Botox, Dysport, Myobloc, and others
Hollywood stars are so nonchalant when talking about botulinum toxin (Botox and similar drugs) 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 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.
In 2023, Public Citizen petitioned the Food and Drug Administration (FDA) to promptly emphasize the risk of iatrogenic botulism in the labeling of approved botulinum-toxin drugs (such as Botox and related drugs) and remove misleading promotional claims from Botox and Botox Cosmetic labeling.
More Information on Botulinum Toxin (Botox, Dysport, Myobloc, and others)
- Letter to the CDC and FDA Regarding Recent Health Advisory on Clusters of Patients with Adverse Events From Certain Botulinum Toxin Injections, April 30, 2024
- CDC Should Promptly Facilitate Administration of Botulinum Antitoxin to People with Illnesses Linked to Counterfeit “Botox”, April 17, 2024
- Petition to the FDA to Strengthen Safety Warning for Botox and Related Drugs and Remove Misleading Claims From Botox/Botox Cosmetic Labeling, December 12, 2023
- 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