Vol. 509 No. 2
113 Ms Fitzgerald asked the Minister for Health and Children the reason so many natural remedies (details supplied) have been placed on prescription from 1 January 2000; the reason it is necessary to put these products on prescription; and if he will make a statement on the matter. [20123/99]
The Medicinal Products (Prescription and Control of Supply) Regulations, 1996 to 1999, set out a list of substances and the circumstances in which products containing those substances are subject to prescription control. Included in the regulations are a small number of so-called natural or herbal substances.
Products containing the herb “hypericum perforatum” (St. John's Wort) are medicinal products and, as such, must, in order that they may be placed on the market in this country, be the subject of product authorisations granted by the Irish Medicines Board under the Medicinal Products (Licensing and Sale) Regulations, 1998, (S.I. No. 142 of 1998).
Examinations carried out by the board have indicated that the products concerned are being promoted and sold for the treatment of patients with mild to moderate depression. The board is of the opinion that patients with this condition should be under the care of a registered medical practitioner and that the condition is not suitable for self-diagnosis or treatment by self-medication using non-prescription medicines. The current position, therefore, is that there are no authorised medicinal products available on the market in this country for the treatment of mild to moderate depression which can be obtained without a medical prescription.
Products containing “Hypericum perforatum” have been reported to act as a monoamine oxidase inhibitors, MAOIs. Such products must, therefore, be used with care because there is a risk of hypertension when they are taken with over-the-counter sympathomimetics – e.g. cough mixtures – antidepressants, or foods containing tyramine, e.g. red wine, cheese.
The advertising literature used in the promotion of these products has also stated that they can be taken "with no side effects" and in some instances are being described as being the "Sunshine Supplement". These statements are not consistent with the published literature which reports side-effects such as photosensitivity – sensitivity to sunlight – gastrointestinal disturbances, fatigue and nervousness.
In the case of progesterone creams, these medicinal products have been subject to medical prescription only control since May 1976.
