Botox Gets Black-Box Warnings
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The New York Times reported that on Thursday, the FDA ordered that Botox and similar anti-wrinkle drugs carry stringent warning labels explaining the potential for the toxic material to spread to other parts of the body. This can cause serious difficulties including problems with swallowing and 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 day before issuing the order, the FDA approved Dysport, another injectable drug derived from botulinum toxin. Dysport will be the first competition to Botox in the United States. Dysport is manufactured by Ipsen, a Paris-based company, and has been approved for use in Europe for years.
Because Botox has faced no serious competition in the US, Botox manufacturer, Allergan, has been able to raise the price annually. Now, with Dysport entering the market at a lower price, this will likely change.
Botulinum toxins are purified forms of botulism and work to temporarily reduce or stop muscle activity. The FDA has approved Botox for use in treating crossed eyes, eyelid spasms, severe underarm sweating and cervical dystonia. Botox Cosmetic is also used to treat frown lines.
This new order for black-box warnings was spurred by a petition from Public Citizen, a public advocacy group that noted the serious health risks and 16 reported deaths connected with Botox injections.
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