July 19, 2008By Julie Earle-Levine
Ever since the 1990s, the anti-wrinkle drug Botox has reigned supreme in the fight against unwanted lines. Many have deemed it and one of its competitors, Myobloc (another drug that uses botulinum toxin to block nerve impulses and "freeze" lines), heaven-sent.
But now the US Food and Drug Administration (FDA) is investigating the product and has warned of possible side effects and even deaths related to Botox use.
According to the consumer advocacy group Public Citizen, there have been at least 16 deaths among 658 reported cases of people in the US "suffering adverse affects from Botox" between November 1997 and December 2006. The FDA is currently reviewing data from clinical studies by the drugs' manufacturers and expects to issue a report in several months.
Public Citizen's initial findings suggest that the use of Botox for cosmetic purposes does not lead to as great a risk of adverse effects as for other "off-label" uses, which would include using treating limb spasticity in a child with cerebral palsy. But the FDA has warned that people using Botox cosmetically should be aware of potential adverse effects, which include breathing problems.
The issue is enough to make consumer groups such as Public Citizen ask that doctors be required to give patients a written warning each time they receive a Botox injection. Last year, drug regulators in the UK and Germany required sterner warnings to be sent to doctors in those countries regarding its use. In France, the government requires doctors to have surgical qualifications to use Botox. Amidst all this, Allergan, the maker of Botox, has said that adverse reactions are rare. "In its entire history, there has never been a single reported death where a causal link to cosmetic Botox was established," said Dr Sef Kurstjens, Allergan's chief medical officer.
Talk of side effects does not appear to be deterring current clients, at least according to Dr David Goldberg, a Manhattan dermatologist and director of the Skin Laser clinic in New York. Goldberg has been offering Botox for more than 10 years and estimates that it makes up 20 per cent of his business. "About 75 per cent of people keep having Botox once they have tried it," says Goldberg of his mainly female client base.
But for those fighting shy of the needle or who would prefer to wait for the results of the FDA investigation, there are plenty of Botox-inspired products on the market - even if the results are not as long-lasting.
For instance, "Glamotox", which contains hyaluronic acid, promises to plump up the skin while you sleep. One recent convert already swears by it. "I'm addicted. It makes me look younger, without having to get Botox or laser," she enthuses.
"Freeze 24/7" is another highly popular moisturiser that professes to freeze wrinkles for up to eight hours, giving the effect of an eye lift - albeit briefly.
Meanwhile, the sale of topical Botox in a gel form - which can be applied to the skin rather than injected - is also a looming reality.
"The intention is to get rid of wrinkles but to preserve facial expression," says Dan Browne, chief executive of Revance, the US-based biopharmaceutical company behind the development. It is currently conducting clinical trials to see whether the gel will have fewer possible side effects than injected Botox.
According to Browne, Botox gel could become a huge chunk of the rapidly growing $14bn facial aesthetic markets. The cool gel will warm up on the skin and, as with Botox, result in visible changes after 24 to 72 hours, with "peak activity" after one week. But the gel would be prescribed and applied by a doctor, meaning you could not just apply it casually at home.