Warning on misuse of wrinkle treatment

The Irish Medicines Board (IMB) is "extremely concerned" about the possible misuse of the medicinal product, Botox.

Used primarily in the treatment of severe muscle disorders, it is sometimes used as a cosmetic treatment for wrinkles. It is not, however, medically authorised for cosmetic use and its safety for cosmetic use has not been established.

When used for cosmetic purposes it is injected into the muscle. Its effect is to paralyse the muscle, causing wrinkles to "disappear" for up to three months. The treatment must be repeated to sustain the effect.

Typically used to "treat" crow's-feet, forehead creases, lines between the eyebrows and bands around the neck, it was recently described in the United States as "the hottest addition to the anti-ageing arsenal".

It should, however, be administered only by physicians, says Dr Joan Gilvarry, of the IMB, who explained that Botox was licensed for medical use only.

"Physicians are entitled to use unlicensed medicines, but only physicians. Use outside this is unauthorised, and anyone being offered Botox for cosmetic treatment must make sure they are dealing with a doctor with the appropriate qualifications and documented expertise in the administration of the equipment.

"And they should ensure that the physician has the back-up facilities in the event of an adverse reaction. Adrenalin should always be on the premises," says Dr Gilvarry.

Investigations by the IMB have identified a number of beauty salons, cosmetic clinics and private individuals who are supplying Botox as a cosmetic treatment without the necessary qualifications.

Dr Gilvarry estimated that the number of such places was "in the hundreds". They were charging up to £1,000 a session.

"It is an expensive and possibly dangerous treatment for wrinkles," she said.

The active substance in Botox is the highly potent neurotoxin, Clostridium Botulinum, type A, which comes from the bacteria that cause botulism in food, she explained. "When this is administered incorrectly, it can have a number of serious side-effects, including ptosis - or eyelid weakness, facial weakness, visual disturbance and corneal ulceration."

In more extreme cases there can be adverse effects on the cardiovascular system, heart rhythm abnormalities and heart attacks. There have been reports of severe allergic reactions, including anphylaxis.

This, said Dr Gilvarry, was characterised by sweating, shortness of breath and eventual collapse with the possibility of death.

There has been one report of a death abroad resulting from unauthorised administering of Botox. Asked whether there had been any adverse reaction to Botox in Ireland, she said it was difficult to know.

Candidates for Botox treatment should be asked, among other things, if they are pregnant, breast-feeding or have any severe neurological disorder. Under the Irish Medicines Board Act 1995, the board has the power to prosecute unauthorised practitioners administering Botox, and the IMB says prosecutions may follow.

Botox is also thought to be effective in the treatment of migraines.