Vol. 532 No. 1
157 Mr. Lawlor asked the Minister for Health and Children if an anti-smoking drug (details supplied) is in use here; if his attention has been drawn to concerns recently expressed in Great Britain regarding the possible side effects of the drug; and if he will make a statement on the matter. [6454/01]
The anti-smoking drug to which the Deputy refers was authorised by the Irish Medicines Board as a prescription-only medicine for use in this country on 23 June 2000.
The Irish Medicines Board is the competent authority for the licensing, supervision and control of medicinal products placed on the market in this country. On becoming aware of reported deaths arising from the use of this drug, the board immediately sought information on the matter from its United Kingdom counterpart, the Medicines Control Agency. The Irish Medicines Board remains in close consultation with the agency which is currently reviewing in full all the United Kingdom reports.
The Irish Medicines Board issued a press statement concerning this drug on 21 February 2001. The board advised that initial information from the Medicines Control Agency suggests that, in many cases, the product appears to have been inappropriately used. The agency does not expect to take any regulatory action at present.
The board reiterated its advice that this medicine should only be used in accordance with the stated recommendations and patient information. Patients were strongly recommended to carefully follow all instructions from health care professionals regarding their treatment, to read carefully any information supplied and to consult their doctor with any problems or uncertainties.
It is considered that, to date, about 23,000 patients have been treated in Ireland with this drug. The Irish Medicines Board gave specific usage and reporting information on the drug to all registered doctors, dentists and pharmacists in its drug safety newsletter of December last and advised all health care professionals to report all suspected adverse reactions associated with the use of the drug to the board.
To date, the board has received 65 reports of suspected adverse reactions associated with the use of this product, the majority of which were in keeping with what is expected for the product. It has received notification of three reports of seizure suspected of being associated with the use of the drug and in respect of which further information is awaited by the board. In addition, one report was received of a fatality, but, following a post mortem, this was found to be unrelated to the use of the drug. The board has no evidence of any other long-term sequelae in these patients.
The Irish Medicines Board, in association with its European counterparts, continues to monitor the safety of this new medicinal product very closely. It also liaises with the company regarding any new safety issues which arise, and will take any regulatory action considered appropriate.
