The Food and Drug Administration has ordered Botox and other similar antiwrinkle drugs to carry the most stringent kind of warning label. The FDA 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 FDA 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 carrying with it the risk of serious difficulties, such as problems with swallowing or breathing.

Requiring a drug to carry the black-box warning – a box with bold-face risk information – is one of the strongest safety actions the FDA can take. Black boxes are typically reserved for medications known to have serious or life-threatening risks. For example, antidepressants carry black boxes warning of the increased danger of suicidal thoughts and actions. The FDA will 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. According to an FDA spokesperson, the problems have occurred primarily in patients who received overdoses of the drug for unapproved treatments.

While the drug – Botox – under the name Botox Cosmetic – is best known for its use to treat frown lines, it’s also approved for several other uses. In 2000, the agency approved a different type of the toxin, Myobloc, to treat cervical dystonia. The agency has now approved Dysport for frown lines and cervical dystonia.

The new FDA requirement for a black-box warning on such drugs came 15 months after the agency received a petition from Public Citizen calling for more substantial warnings. In its petition, the consumer group said that the FDA had received reports of 180 serious health problems and 16 deaths connected to the injections. Interestingly, in its response to the petition, the FDA says it has identified even more reports of complications, including 225 reports of problems caused by the drug spreading from the injection site to distant parts of the body. Dr. Sidney M. Wolfe of Public Citizen says there would have been fewer problems if the FDA had acted a year earlier.

Source: New York Times

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