F.D.A. Raises Botox Warning to Highest Level

Saturday, May 02, 2009

This week was not a good one for drug manufacturer Allergan. On Wednesday, the Food and Drug Administration (FDA) approved the first real competition to the California-based company’s big money maker, Botox, and the very next day, FDA officials decided that all anti-wrinkle drugs must now be sold with the infamous “black box” warning label. Such warnings are reserved for medications known to have serious or life-threatening risks. The FDA explained that Botox and other remedies using botulinum toxin have the potential to spread throughout the body and cause problems, particularly with swallowing or breathing. Manufacturers of anti-wrinkle drugs also will now be required to send letters to doctors warning of potential side effects and to publish medication guides for patients before they receive injections.

 
The new competition for Botox is Dysport, made by Paris-based Ipsen. Worldwide sales of Botox in 2008 totaled $1.3 billion, thanks in large part to the absence of serious competition in the U.S., where Allergan has been able to raise the price annually. Some analysts predict Dysport has the potential to capture up to 20% of the U.S. market.
-Noel Brinkerhoff
 
F.D.A. Orders Warning Label for Botox (by Natasha Singer, New York Times)

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