Dáil Éireann díospóireacht -
Tuesday, 12 Jun 2001

Vol. 537 No. 5

Written Answers. - Beauty Treatments.

Deirdre Clune

Ceist:

305 Ms Clune asked the Minister for Health and Children the system of registration in place for those providing beauty treatments; if he is satisfied the correct controls are in place; and if he will make a statement on the matter. [16626/01]

Minister of State at the Department of Health and Children (Ms Hanafin)

I am not aware that there is a system of registration in place for those providing beauty treatments.

If the Deputy's concern relates to the use of Botox by those providing beauty treatments, I advise the Deputy that the Irish Medicines Board issued a press statement on 23 May 2001 expressing concern about the possible misuse of this product.

The board in its statement indicated that Botox is a medicinal product and is primarily used in the treatment of severe muscular disorders. It warned that the active substance in Botox is the highly potent neurotoxin, Clostridium botulinum toxin type A. Under the conditions of the marketing authorisation the product should be given only in accordance with its authorised use by physicians with appropriate qualifications and documented expertise in the administration and uses of the required equipment.

Investigations by the Irish Medicines Board have identified a number of beauty salons, cosmetic clinics and private individuals who are supplying and administering Botox as an injectible cosmetic treatment for wrinkles. Botox, or any of the other marketed Clostridium botulinum toxins are not authorised for cosmetic use and their safety under these conditions has not been established. The board pointed out that unauthorised persons engaged in this activity are in contravention of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996, (S.I. No. 256 of 1996) and that any such business and/or unauthorised individuals will be liable to prosecution under the Irish Medicines Board Act, 1995.

The Irish Medicines Board in its statement warned that Botox may have a number of serious side effects some of which include ptosis, eyelid weakness, facial weakness, visual disturbance and corneal ulceration. On rare occasions it has been associated with adverse events involving the cardiovascular system, including heart rhythm abnormalities and heart attacks. There have been reports of severe allergic reactions including anaphylaxis following administration of the injection and in rare cases there have been fatalities. In the interests of safety, the board has advised potential customers that this is a prescription only product and that only registered medical practitioners or dentists should administer this medicine in accordance with the conditions of the licence.