FDA Slaps Black Box Warning on Botox, Other Anti-wrinkle Drugs
Posted by
Camryn HansenMay 01, 2009 10:25 PM
We all knew it was too good to be true. Decades’ worth of wrinkles aren’t “gone, just like that”; Botox carries a risk of serious side effects, including swallowing and breathing problems.
That’s because Botox is derived from the paralytic agent botulinum toxin, which in its natural form causes botulism, a potentially fatal paralyzing disease. Hence the “tox” in the name.
Thursday, the FDA issued the order to place black box warnings, usually reserved for drugs like Celebrex that have caused fatal heart attacks, strokes or other life-threatening conditions, on Botox and like injectable toxins.
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.
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. -Natasha Singer, The New York Times
According to Allergan, Botox’s maker, 2008 sales totaled about $1.3 billion. Currently, it is approved to treat such conditions as eyelid spasms, crossed eyes, cervical dystonia, excessive underarm sweating, and facial wrinkles.
Dysport, which has typically been priced lower than Botox in Europe, made $189 million last year. On Wednesday, the FDA approved Dysport in America for use on wrinkles and cervical dystonia. Medicis Pharmaceutical plans to begin marketing the drug in the next two months.
Fifteen months before the FDA issued the black box warning, the advocacy group Public Citizen petitioned the organization to put more severe warnings on Botox, reporting that there had been 180 serious health problems and 16 deaths in connection with the injections. In a response to Public Citizen last week, the FDA announced that a full 225 people had reported complications as a result of the drug spreading from the injection site to other parts of the body.
Heed the FDA’s black box warning and avoid Botox. The temporary fix isn't worth the risk.