It is not unusual for drugs to be derived from substances that in other contexts would be considered dangerous. Many cancer medications are in this category.
It is also common for drugs that are licensed for a particular condition to be used “off label” to treat other problems.
So even though botulinum toxin — better known as Botox — is one of the most powerful nerve poisons known, its rise as a medication in recent decades is not as startling as some might think.
ILLUSTRATION: NY TIMES NEWS SERVICE
But all drugs, even the mildest over-the-counter medications, have unwanted side effects. And as the number of uses for botulinum toxin grows along with the number of people who use it, healthy or otherwise, it is no surprise that reports of unwanted effects are growing, too.
Though this toxin is extremely deadly when ingested, as a muscle injection it has found a vast clientele among otherwise healthy people. As Botox Cosmetic by Allergen, it is widely used by many women and men in affluent countries to relieve the visible ravages of age, at least temporarily.
A friend recently told me with slight exaggeration that “every woman” in Argentina in her 40s regularly had Botox injections to smooth out facial wrinkles, just as casually as she might have her hair dyed to hide the encroaching gray.
I can only wonder what these women will do in their 50s and 60s, when wrinkled skin is no longer confined to their faces. Given the prevalence of ageism and the perennially youthful images paraded before us in the media, there is no telling to what limits women — and some men — may go to in an effort to physically deny their age.
Botulinum toxin is produced by the bacterium Clostridium botulinum. It grows in the absence of air and has a lethal reputation as a food contaminant, especially in improperly canned or preserved foods. It weakens muscles and can cause paralysis, including life-threatening breathing problems. The toxin acts on peripheral nerve endings, preventing the release of the neurotransmitter acetylcholine, which conveys nerve signals to muscles.
In tiny amounts injected into muscle, it can relieve spasms by causing muscles to relax. The effect lasts for months; when it wears off, the toxin can be reinjected.
The toxin was first used as a drug in the 1970s to treat strabismus, deviant eye muscles that cause double vision. It has since proved remarkably effective in treating all manner of problems caused by overactive muscles, like neck and limb spasms, unwanted movements, abnormal postures, excessive sweating and pain associated with various disorders, including migraine headaches. One of its newest uses, off label, is treating overactive bladder that is unresponsive to other remedies.
Jean Carruthers, an ophthalmologist at the University of British Columbia who in 1987 was among the first to observe Botox’s cosmetic potential, has likened it to penicillin both for its versatility and for its derivation from a common bacterium. Carruthers and her husband, Arthur, a dermatologist, noted that patients she treated with Botox to relax spastic eye muscles also often experienced a smoothing of frown lines between their brows.
Although there are seven types of the toxin, each with a specific mode of action, just two, A and B, are currently used medically. Of the products available in the US, Botox and Botox Cosmetic are derived from botulinum toxin A and Myobloc from B. The cosmetic formulation uses a much lower dose of the toxin than the one used to treat major muscle spasms.
In February, the US Food and Drug Administration, which has a continuing safety review of these products, notified the public about reports of ill effects associated with the drugs. Most of the serious cases resulted from medical, not cosmetic, uses of the toxin. Medical treatments typically require much larger doses, and many of the patients have other health problems that increase their risk.
The reactions, which included serious and sometimes deadly effects like respiratory failure, involved a range of doses and uses, many of them off label. The most severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use in children and adults.
Because this safety review depends on voluntary reports from medical and patient sources, it is often not possible to tell exactly what is to blame for the unwanted effects — poor technique, wrong dosage, an underlying medical problem or a hazard of the drug itself.
Public Citizen, a consumer advocacy organization in Washington, has petitioned the drug agency to force manufacturers to warn doctors about the reported complications. The group reviewed the agency’s adverse-event reports and found 180 cases of serious effects like pneumonia and difficulty swallowing and breathing, as well as 16 deaths. In September 2005, the US Centers for Disease Control and Prevention reviewed 1,437 adverse reports: 406 after medical use of Botox (217 of them serious effects) and 1,031 after cosmetic use (36 of them serious).
The proportion of serious reports was 33-fold higher for patients treated for medical problems than for those receiving cosmetic treatments.
Although it has long been known that injecting the toxin can cause unwanted effects in adjacent muscles — for example, injections to smooth creases around the eyes may cause temporary drooping of the eyelids — recent concerns involve what are called systemic reactions, or effects on distant muscles.
Dermatologists who use the drug for wrinkle reduction say that in experienced hands and properly diluted and administered, Botox is extremely safe. The worst disasters have occurred when unqualified practitioners administered the drug.
The drug agency has told doctors who use the toxin to give patients and their caregivers information about the signs and symptoms of adverse effects and the need to seek “immediate medical attention if they have worsening or unexpected difficulty swallowing or talking, trouble breathing or muscle weakness.” Doctors and patients should also know that adverse effects do not always occur right away, the agency said, but may show up even weeks after treatment.
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