The
company that makes anti-wrinkle treatment Botox is misleading
patients over the risks of the treatment, say the US authorities.
Thousands
have had Botox injections.
The
Food and Drugs Administration says that advertising on the
web and in print does not reveal that more than four in ten
people who have the treatment suffer some form of undesired
side-effect.
The vast majority of these are minor and short-lived - although
the treatment can lead to drooping eyelids, an effect which
can last for weeks.
The popularity of Botox has soared
In a letter to Allergan - the company which makes Botox -
Steven Masiello, from the FDA's "Office of Compliance and
Biologics Quality", accused the firm of "minimising important
risk information".
"The agency has concluded that your journal advertisements
are false and/or misleading because they falsely identify
the product as a cosmetic treatment, fail to reveal material
facts about the product's use, and minimise the risk information
presented."
'Off-label'
In the UK, Botox is not even licensed for use in cosmetic
treatments - although it is perfectly legal for doctors to
use it "off-label" in this way.
However, Allergan's US website - accessible from the UK -
still carries some of messages about the drug which the FDA
would like to see removed.
Botox is a powerful poison which has the ability to paralyse
muscle.
In tiny amounts, it is injected into facial muscles, relaxing
them, which can improve the appearance of wrinkles.
Dr Anthony Ward, an expert in rehabilitation medicine who
uses Botox regularly to help patients suffering from cerebral
palsy.
He said: "I tell my patients that it's the safest drug I use.
"It has a very low risk of adverse effects, and any that do
arise are temporary."
Growth industry
It is the fastest growing cosmetic treatment in the US, and
sales could hit the £1 billion mark annually within the next
few years.
Celebrities such as Liz Hurley and Cliff Richard have admitted
having the injections to improve their appearance.
Botox is also used in the relief of cerebral palsy symptoms
and those of certain types of chronic pain.
The most common side-effects of the treatment are headache
and nausea, although its use has been linked with respiratory
infection and "flu syndrome", as well as temporary drooping
of the eyelids.
Thousands
have had Botox injections.
