The F.D.A. issued that order the day after the agency approved a new drug, Dysport, that is expected to be the first real challenger to Botox in the United States. Like Botox, Dysport is an injectable drug derived from the paralytic agent botulinum toxin.
The F.D.A. said such drugs must carry warning labels explaining that the material has the potential to spread from the injection site to distant parts of the body — with the risk of serious difficulties, like problems with swallowing or breathing.
Requiring a drug to carry a box with bold-face risk information — a so-called black-box warning — is one of the strongest safety actions the F.D.A. can take. Black boxes are typically reserved for medications known to have serious or life-threatening risks. Antidepressants, for example, carry black boxes warning of the increased danger of suicidal thoughts and actions.
The F.D.A. said it would also require makers of injectable toxins to send doctors letters warning of their risks and to produce a medication guide to be given to patients at the time of injection.
In a conference call with reporters on Thursday, an F.D.A. official said that the problems had occurred mainly in patients who received overdoses of the drug for unapproved treatments, like limb spasticity in children with cerebral palsy.
Comment from Leslie
Injectable toxins – does that mean Gardasil/vaccinations? And now Botox?
“A woman’s body is the battlefield where she fights for liberation. It is through her body that oppression works, reifying her, sexualizing her, victimizing her, disabling her.”
Germaine Greer: The Whole Woman