Botox is known for smoothing furrowed brows. Now it's causing a few.
The Food and Drug Administration last month issued a statement that Botox and another botulinum toxin drug, Myobloc, have been linked to serious respiratory and swallowing problems and at least one death.
And consumers seeking to smooth their facial lines want to know: Is it safe?
The primary fact to keep in mind, doctors say, is that Botox -- the only botulinum toxin drug approved in the U.S. for cosmetic purposes -- has a stellar safety record.
Since 2002, when the drug was approved for temporary treatment of so-called glabellar lines -- the lines between the brows -- more than 13 million doses have been administered for that purpose, including more than 3 million doses in 2006. The most common side effects are bruising and pain at the site of the injection.
Although the FDA did not list in detail the number and nature of the cases that it's reviewing, the agency later reported that it was looking at fewer than 100 incidents of serious adverse reactions. Most of these reactions followed treatment for medical conditions, such as juvenile cerebral palsy, in which Botox is used to relax tense, rigid muscles. In these treatments, the quantities used are much higher than those administered for cosmetic purposes.
There have been a few reports of serious side effects with cosmetic use, "but it's extremely rare," said Russell Katz, director of the FDA's division of neurology drugs in a Feb. 8 conference call with news media. "And it's not even really clear whether or not those events could be attributed to the treatment."
Further, Katz reported that the FDA is not aware of any deaths directly caused by cosmetic use of Botox, although it is continuing to investigate.
Dermatologists have rallied to the support of Botox.
"The consensus is that there have been no shown issues related to the aesthetic uses of Botox," says Dr. Neil Sadick, clinical professor of dermatology at Weill Medical College of Cornell University in New York. Sadick canvassed his colleagues after the FDA released its statement.
But not so fast, says the consumer advocacy group Public Citizen.
In its own analysis of the FDA's database, Public Citizen in January reported 180 serious adverse reactions and 16 deaths linked to the drug between 1997 and 2006, with one death linked to cosmetic use.
