WASHINGTON – The government has approved Botox, a purified strain of the toxin that causes botulism, to smooth frown lines – a decision likely to lead to even wider use of the wildly popular injections.
Botulinum toxin is one of the most poisonous substances on Earth. But injected in purified, extremely small doses, it can be used safely to treat certain neuralgic disorders, by temporarily paralyzing muscles that cause involuntary spasms.
The Food and Drug Administration approved that medical use of Botox years ago. But it is legal for doctors to use a prescription drug for other reasons – and two years ago, Botox suddenly became the rage among plastic surgeons and their customers eager for new ways to ease wrinkles.
By formally approving a cosmetic use for Botox yesterday, the FDA cleared the way for maker Allergan Inc. to advertise the injections as a wrinkle smoother, potentially making it even more popular.
Dr. Larry Weinstein of Plastic Surgery Associates in Chester Township said he started administering Botox treatments four years ago. He had 83 Botox patients last year, up from 15 in 1999. Nationally, plastic surgeons performed 1.6 million Botox treatments last year, up from 100,000 in 1999.
“I was reticent about using it initially because of the concern that botulism, or Botox, is derived from a bacteria which is potentially poisonous,” Weinstein said. “But in selected safe doses, it’s extremely useful to control forehead vertical lines, worry lines, crow’s-feet and deep vertical lip lines.”
Frown lines, those furrows between the eye-brows, typically are formed by excessive contraction of two forehead muscles. Injecting small doses of Botox into those muscles can weaken or paralyze them, thus temporarily improving the appearance of the wrinkles.
It is only temporary: In one study of Botox injections, the severity of frown lines was reduced for up to 120 days.
Botox should be injected no more often that once every three months, and the lowest effective dose should be used, the FDA cautioned.
“You must wait a minimum of three to four months between treatments because if you do it more frequently, people can have an antibody reaction to it, which makes the toxin ineffective,” Weinstein said. “The toxin has an effect for three, four or six months on some patients, and there may be a qualitative or quantitative effect of use over time. Eventually, the muscle doesn’t come back as strong.”
There are side effects, including headache, droopy eyelids, nausea and flu symptoms. Some patients – fewer than 3 percent in the study – also experienced face pain, redness at the injection site and muscle weakness. Those side effects were generally temporary but could last several months, the FDA warned.
Some of Weinstein’s Botox patients have found tension and migraine headaches have gone away after treatment, he said, adding that neurologists sometimes use Botox to treat such headaches. He’s never seen a patient with nausea or flu symptoms and only on one occasion did he have one with a droopy eyelid.
“Some people have an anatomical variant of the eye muscles,” he said, “so that when you try to control the muscles involving the crow’s-feet, the muscle that affects the eyelid is affected. It was recently described in one of the journals. I’ve only seen it once. It resolves. It goes away.”
Cost varies around the country but average about $400 a treatment, which is what Weinstein charges.
Analysts estimate Botox did $300 million in worldwide sales last year, with up to half that amount related to cosmetic use.