In fact, Allergan's promotional materials for patients sound as though the product might be found in the local health store. Botox is a "natural, purified protein derived from a bacterium in much the same way penicillin is derived from mold," some company advertisements and brochures state. In June, the FDA warned Allergan that its magazine ads for Botox "falsely identify your product as a cosmetic treatment, fail to reveal material facts about the product's use and minimize the risk information presented."
The FDA argues that although the drug's brand name is Botox Cosmetic, it is approved only for "severe glabellar lines," which are the wrinkles between the brows, and not "frown lines," as stated in Allergan's ads. In response, Allergan pulled the ads. New ads, without the disputed text, started appearing in magazines this month.
For The Record
Los Angeles Times Thursday September 25, 2003 Home Edition Main News Part A Page 2 National Desk 1 inches; 50 words Type of Material: Correction
Botox treatment -- In a Health section article Monday about Botox, a photo caption labeled "Wining and Dining Clients" mistakenly implied that alcohol was being served at Dr. David Amron's Beverly Hills office. No alcohol was served at the gathering, and the glasses shown in the photograph held mineral water.
For The Record
Los Angeles Times Monday September 29, 2003 Home Edition Health Part F Page 10 Features Desk 1 inches; 49 words Type of Material: Correction
Botox treatment -- In a story about Botox last Monday, a photo caption labeled "Wining and Dining Clients" mistakenly implied that alcohol was being served at Dr. David Amron's Beverly Hills office. No alcohol was served at the gathering and the glasses shown in the photograph held mineral water.
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The record so far
Allergan officials stress Botox's safety record, dating to the late '70s, when clinical trials of the drug began.
Indeed, reported difficulties with the drug are rare with just seven people in the 1990s suffering serious side effects, according to Allergan. In California, the state medical board reports just six complaints against Botox in the last two years; none of the complaints resulted in disciplinary action against any doctors.
The only known Botox-related death, according to Allergan, was that of an elderly woman with a preexisting neurological condition who suffered from head and neck spasms and had difficulty swallowing. After Botox treatment, her symptoms were exacerbated.
According to documents filed with the FDA, the agency has received dozens of reports of severe side effects, including some deaths and prolonged hospitalizations, possibly associated with Botox use from 1989 to 2001. The FDA said it has not studied the events sufficiently to determine if Botox was the cause or a contributing factor in those incidents. FDA officials say an ongoing analysis of these and other reports has turned up nothing alarming..
"We haven't seen unusual kinds of events that would worry us about the safety of this product," said Susan Ellenberg, the FDA's director of the Office of Biostatistics and Epidemiology.
Allergan consultant Alastair Carruthers, the Canadian dermatologist who, with his ophthalmologist wife, Jean Carruthers, popularized the use of Botox as a wrinkle cure in the '80s, said he's confident of its safety.
First, he said, the recommended 20-unit doses are far too minuscule to damage the body. Second, the muscle soaks up the drug before it ever enters the bloodstream. "What we presume is, when it's injected, tiny, tiny amounts get into the circulation ... [and] bind to the nerve muscle junction elsewhere in the body," Alastair Carruthers said. However, he added, that "doesn't translate into any clinical effect. It's just in laboratory tests."
But James Adams, an associate professor at USC's School of Pharmacy who has studied Botox for more than 15 years, said the risks increase when improperly administered. "If it's injected too deeply, it can go into blood, not muscle," said Adams. "Then you could get all the classical signs of botulism. People can die from having too much botulinum in their blood."
Most doctors interviewed for this story don't believe the drug can lead to symptoms of botulism. They share Carruthers' view that years of clinical experience prove the drug's safety.
Other physicians, though, caution that the drug's side effects deserve more study.
Botox "works by causing damage to the nervous system," British biochemist Nicholas Abrishamian said in an article in the Lancet, a prestigious British medical journal, in September 2002. "How do I know that it's not going to slowly cause even more nervous system damage?"
UCLA neurologist Andrew Charles, who treats Medavoy and blames Botox for her months-long illness, believes that the risk of the drug damaging the body is higher than most physicians realize. "Some toxin may travel up the nerve into the brain or spinal cord," he said. "The potential consequences of this kind of spread are not known."
Each warning label lists many unknowns associated with Botox, including how the drug affects pregnant women, whether it's excreted in human milk, and its relationship to rare cases of "significant disability," pneumonia and death. The label also cautions that in patients with preexisting neuromuscular disorders Botox may cause "clinically significant systemic effects," including the inability to swallow or breathe.
The effect of doses higher than 20 units is unknown, but physicians typically treat head and neck spasms, migraines and excessive sweating with doses from 50 to more than 300 units.
Although a 10-year Italian study published last year on the drug's effectiveness on facial spasm concluded that side effects to Botox were minimal and transient, longer-term effects are unknown.
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Patients not aware
