Botox gets a new warning label

new warning label on Botox and Botox Cosmetics in Canada that advises the toxin can spread to other parts of the body, to potentially fatal effect, has been met by a decided absence of brow-furrowing among those who use the drug cosmetically, and not only because their foreheads can’t move. They’re confident that the revised monograph issued this week that states possible symptoms of “distant toxin spread ” can include muscle weakness, difficulties swallowing, pneumonia, speech disorders and breathing problems, doesn’t apply to them.

Botox, a muscle relaxant manufactured by Irving, Cal.-based Allergan Inc., has two uses: medical and cosmetic. It has been licensed in Canada for an increasing number of medical afflictions, including facial nerve disorders and cerebral palsy, since 1990. Since 2001, the toxin has been approved to treat ‘frown lines’ between the eyes, ‘crow’s feet’ and forehead wrinkles. Last February, the U.S. Food and Drug Administration warned that distant spread phenomenon had been reported in both in FDA-approved and non-approved uses of Botox. The new cautionary labelling in Canada stemmed from an investigation launched last October by Health Canada after five Canadians died following Botox injections. The agency also looked into eight reports of serious reactions following Botox treatment. Only one of the 13 had received Botox for wrinkles, and none was medically confirmed as “distant toxin spread,” Heath Canada reports.

Doctors downplay the risks for the tens of thousands of Canadians who use Botox for a smoother visage. Nowell Solish, a Toronto-based cosmetic dermatologist and associate professor at the University of Toronto, says he has fielded a lot of questions since Health Canada announced its investigation. “I’ve never seen an instance of ‘distant spread,’” he says. “And there are very few people who inject more Botox in this country than I do.” Solish, who performs thousands of injections annually at an average cost of $500 to $1,000 a pop, says “distant toxin spread” is a risk for those who use the toxin medically to relieve neurological problems or muscle spasms due to the higher dosages involved. “An adult with spasticity can receive 800 to 1,000 units while someone coming to me for a forehead will typically get 50 units,” he says.

Solish says that there can be problems if the toxin is administered improperly: “If I was someone with a severe medical or neurological problem I would want to see a doctor who does this all the time,” he says. The new warning hasn’t frightened cosmetic users, he says. Indeed, the economic downturn has bought new customers, among them an out-of-work woman he saw this week. “I said, ‘What are you doing here? This is discretionary funds,’” he says. “She said, ‘I’m interviewing for jobs and I want to look good. I want to look young; I don’t want to look old.’ ”

Indeed, injecting the toxin has been normalized as a routine part of looking one’s best for both women and a growing number of men. Fashion Television host Jeanne Beker sees the procedure as a necessity in her field: “Most female broadcasters of a certain age see it as an obligation,” she says. As for the risk of “distant toxin spread,” Beker’s sanguine: “My doctor assures me it’s safe and I trust him completely.”