Question of the Week

February 12, 2008


More and more people (of all ages) are considering Botox® treatment as an "easy" way to get the look they want without the dangers of a more invasive surgery. For some, this raises concerns. Just a couple weeks ago it was reported that:

"A consumer group, Public Citizen, is lobbying U.S. authorities to strengthen the health warning on Botox and its kin, Myobloc. They want to see a 'black box' warning -- similar to the health caveat plastered on cigarettes -- adhered to containers of the substances. ...[T]he group studied 180 reports submitted to the FDA and noted that in the 16 deaths caused by Botox, four of those fatalities occurred in patients under 18. ... According to the [American Society of Plastic Surgeons'] 2006 statistics, 22,795 Botox injections were given to teenagers. (The ASPS tallies injections, rather than patients.)",1,1935309.story

According to the FDA (Food and Drug Administration), Botox® is:

"Botulinum Toxin Type A (Botox Cosmetic) is a protein complex produced by the bacterium Clostridium botulinum, which contains the same toxin that causes food poisoning. When used in a medical setting as an injectable form of sterile, purified botulinum toxin, small doses block the release of a chemical called acetylcholine by nerve cells that signal muscle contraction. By selectively interfering with the underlying muscles' ability to contract, existing frown lines are smoothed out and, in most cases, are nearly invisible in a week."

The reason Botox® works is because the muscles into which it is injected are paralyzed by the botulism toxin.

"Botulism is a rare but serious paralytic illness caused by a nerve toxin that is produced by the bacterium Clostridium botulinum. There are three main kinds of botulism. Foodborne botulism is caused by eating foods that contain the botulism toxin. Wound botulism is caused by toxin produced from a wound infected with Clostridium botulinum. Infant botulism is caused by consuming the spores of the botulinum bacteria, which then grow in the intestines and release toxin. All forms of botulism can be fatal and are considered medical emergencies. Foodborne botulism can be especially dangerous because many people can be poisoned by eating a contaminated food."

While the toxin produced by Clostridium botulinum can cause botulism, the FDA ruled Botox® to be safe because of the small quantities of the toxin being used and because of the location into which it was being injected.

"Although there is no chance of contracting botulism from Botox injections, there are some risks associated with the procedure. If too much toxin is injected, for example, or if it is injected into the wrong facial area, a person can end up with droopy eyelid muscles (ptosis) that could last for weeks. This particular complication was observed in clinical trials. Other common side effects following injection were headache, respiratory infection, flu syndrome, and nausea. Less frequent adverse reactions included pain in the face, redness at the injection site, and muscle weakness. These reactions were generally temporary, but could last several months. While the effects of Botox Cosmetic don't last, still, people don't seem to mind repeating the procedure every four to six months in order to maintain a wrinkle-free look. Battling the signs of aging in a non-invasive way, after all, is part of the allure of the product--that and the fact that there are no unsightly scars, and that there is very little recovery time with the procedure. The FDA recommends that Botox Cosmetic be injected no more frequently than once every three months, and that the lowest effective dose should be used."

By 2004, reports of lawsuits and problems with injected botulism toxin had made the news:

"Investigators working with the Centers for Disease Control and Prevention have determined what caused the paralysis in four people who received Botox injections at a South Florida clinic. For two weeks, health officials have feared that four patients who received the injections were suffering from botulism. Tuesday, the Florida Department of Health confirmed three of four patients who became ill tested positive for botulism. ... Investigators say an unregulated vial of Botox could contain more toxin than indicated on the label, which could lead to botulism. State health officials say they have an ongoing battle to root out such activity and they hope to learn more about this case with the help of the patients being treated for botulism. ... Health officials say botulism patients can be paralyzed for up to a year until the toxins are flushed from their systems."

When those giving the injections opt for unregulated products, or products are used for off-label treatments, the chance of a possible adverse reaction increases.

Once again, botulinum toxin injections have made the news.

"Botulinum toxin injections, best known for smoothing wrinkles, have been linked to cases of serious reactions, including death, the Food and Drug Administration announced Friday. ... Most of the severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use, [Russell Katz, director of the neurology products division at the FDA's Center for Drug Evaluation and Research] said. Such off-label uses are appropriate if the physician believes they are, Katz said.

Questions of the Week:
When considering Botulism toxin (Botox®) to treat a medical condition, what possible positive and negative effects should patients weigh? How does this balance change when consumers consider Botulism toxin for cosmetic purposes? If you knew a friend or family member was considering Botulism toxin what would you want them to know about the possible side effects? What do you think that a person considering Botulism toxin treatments needs to know about the person, or the clinic, administering the treatments? Why do you think that some people do not consider Botulism toxin injections to be a medical procedure?

Please email me with any ideas or suggestions.
Note: Due to increasing amounts of SPAM sent to this account, please include "QOW" in the subject line when sending me email.

I look forward to reading what you have to say.

Health Community Coordinator
Access Excellence @ the National Health Museum

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