Statement: FDA Grants Public Citizen Petition on Botox

April 30, 2009

Peter Lurie, M.D., Deputy Director, Health Research Group at Public Citizen

Public Citizen welcomes the Food and Drug Administration’s (FDA’s) announcement today that it has granted Public Citizen’s January 2008 petition that sought to warn doctors and patients about dangers associated with the use of botulinum toxin (Botox, Myobloc, Dysport). In particular, the FDA will require a boxed warning (the strongest warning it can require), a letter to doctors and a medication guide to be handed to patients at the time of injection – all warning of the potential for the product to spread from the point of injection to cause swallowing and breathing problems. The warning will apply to both therapeutic and cosmetic forms of botulinum toxin.

This new information will allow doctors and patients to make more informed decisions about the balance between the benefits and risks of these drugs and might allow patients to detect the symptoms of spread of the toxin sooner, permitting medical intervention. The FDA even went beyond our petition to require companies to conduct post-marketing studies when the drug is used for the treatment of spasticity associated with cerebral palsy, an unapproved use. Although this action could have been taken by the previous administration, we hope this warning indicates that the winds of change are blowing at the FDA.

READ Public Citizen’s January 2008 petition to the FDA.
READ the FDA's response to Public Citizen's petition (PDF).