FDA Approves Botox Injections

Monday, April 15th 2002, 12:00 am
By: News On 6

WASHINGTON (AP) _ 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 on Monday, the FDA cleared the way for maker Allergan Inc. to advertise the injections as a wrinkle smoother, potentially making it even more popular.

Frown lines, those furrows between the eyebrows, are typically formed by excessive contraction of two forehead muscles. Injecting small doses of Botox into those muscles can weaken or paralyze those muscles, 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 than once every three months, and the lowest effective dose should be used, the FDA cautioned.

There are side effects, including headache, droopy eyelids, nausea and flu symptoms. Some patients _ less 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.

Cost varies around the country but average about $400 a treatment.

Analysts estimate Botox did $300 million in worldwide sales last year, with up to half that amount related to cosmetic use.