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Patients 'Misled' Over Botox Safety

Jun 26, 2003 | BBC

The company that makes anti-wrinkle treatment Botox is misleading patients over the risks of the treatment, say the US authorities.

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.

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."


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.

A spokesman for Allergan told BBC News Online that it was confident that minor changes to their literature would satisfy the FDA.

"Botox has an excellent safety profile," she said.

"We've always had a good relationship with the FDA, and letters such as this are relatively common in the pharmaceutical industry."

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