Just how safe is the anti-wrinkle drug Botox? That’s the question raised by new research which found that, contrary to popular belief, the toxin can spread in the body - potentially putting patients’ health at risk.Botox is one of the fastest-growing cosmetic treatments in the world and is also increasingly being used as a medical treatment for a range of conditions, including excessive under-arm sweating, incontinence, migraine, stroke, and muscle spasms in children with cerebral palsy.
The drug is made from a toxin produced by the bacterium clostridium botulinum, one of the deadliest germs known to man.
Botox is made from a toxin that causes botulism, the progressive paralysis of muscles
The toxin causes botulism, a severe and often fatal condition whereby the muscles become progressively paralysed - the heart and breathing muscles stop, causing death.
It is this ability to temporarily paralyse muscles which has been harnessed by the medical profession. And while in large doses Botox can be fatal, using small, carefully applied doses to paralyse and therefore relax an overactive muscle can be useful medically.
Relaxing the rigid muscles after a stroke can mean a patient may find it easier to dress themselves, just as relaxing the muscles of the head and neck can relieve the pain of certain types of migraine, or relaxing one of the muscles that controls the bladder will relieve incontinence.
Botox was first licensed for cosmetic use in 2002; tiny amounts injected into the face block nerve signals and cause paralysis, relaxing the muscles and smoothing out wrinkles.
It has been widely assumed that Botox stayed in the muscle and was therefore safe - but new research contradicts this.
In the study, conducted at the University of Calgary, in Canada, and published in the Journal of Biomechanics, it was found that the product is not as easy to control as previously thought.
The research was led by scientist Dr Walter Herzog, who received the American Society of Biomechanists’ highest honour for his work last year.
He had been using botulinum as part of his study into osteoarthritis when he noticed that the toxin didn’t just affect the muscle in which it was injected.
Experimenting on cats, his team injected the toxin into a muscle at the back of the leg. Four weeks later, the time it takes for Botox to have its full effect, they measured the strength of this muscle, and that of a neighbouring muscle.
Herzog says: “What we found was that the toxin passed easily into the surrounding muscles and weakened all the muscles in the area. The results support other research that has already shown that botulinum can pass through muscle fascia (the packing tissue around muscles).
“Our research showed that the toxin can also affect the working of the neighbouring muscles.”
He adds: “While I see the benefits of it as a therapeutic tool, its applications in humans are increasing and it is important we understand more about this product, which is a toxin.”
This research comes amid investigations by the American Food and Drink Administration (FDA) into reports of children’s deaths, and severe side-effects for others treated for a variety of medical conditions with Botox and related products.
The most serious cases were in children with cerebral palsy being treated for spasticity - rigid muscles.
They experienced difficulty swallowing, muscle weakness and breathing problems - mimicking the symptoms of botulism poisoning - which appeared to be related to the spread of the botulinum toxin from the site of injection
The FDA is not advising doctors to stop prescribing the drug, but they are conducting a safety review and say the reactions may be due to overdosing.
However, they are warning patients that they should receive immediate medical attention if they have worsening or unexpected difficulty in swallowing or talking, trouble breathing or muscle weakness following any injection of Botox.
According to Rajiv Grover, secretary of the British Association of Aesthetic Plastic Surgeons, the doses used cosmetically are 50 to 60 times less than those used to treat some medical conditions.
“Along with my colleagues I’ve treated thousands of patients and if we saw a lot of diffusion to other muscles of the face we would see a lot of complications which we certainly do not.
“The single most important factor in getting a good result from Botox is not the drug itself but the skill of the person who injects it.”
Dr Antony Fulford-Smith, spokesman for Allergan, the manufacturer of Botox, says: “Dr Herzog’s research was on cats and therefore it is inappropriate to make any conclusions at all about the safety of BOTOX in relation to humans.
“It was a laboratory experiment using doses that would not normally be used in a therapeutic situation.”
“BOTOX has been used worldwide to treat millions of people for many conditions for nearly 20 years, providing huge relief in many cases. We closely monitor any adverse reactions and if used as indicated and injected in the right dose it is very rare for there to be any serious side-effects in relation to the spread of the toxin.”
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