Skip to main content
Normal View

Dáil Éireann debate -
Tuesday, 23 Nov 1999

Vol. 511 No. 3

Written Answers. - Medicinal Products.

Question:

232 Dr. Upton asked the Minister for Health and Children the steps, if any, he has taken to respond to concerns regarding adverse side effects to the drug Roaccutane if he has met the RAGE group in this regard; the contact, if any, he has had with the Irish Medicines Board in this regard; and if he will make a statement on the matter. [24423/99]

The Irish Medicines Board is the competent authority for the regulatory control of medicinal products in Ireland.

Roaccutane, isotretinoin, is a vitamin A derivative used in the treatment of acne. In Ireland, it is authorised by the Irish Medicines Board for the treatment of severe acne that is unresponsive to other treatments, and its availability is limited in that it must be prescribed and its use monitored by a consultant dermatologist. I am aware that there have been reports in Ireland in the past of possible adverse reactions to the drug, including two reports of suicide suspected in association with its use, one of which I understand refers to an Irish person who was resident in the UK and treated there.

The Irish Medicines Board has in the past, and continues on an ongoing basis, to actively monitor all available data on roaccutane, including reports of adverse reactions, which it reviews both internally with its own experts and with the other European regulatory agencies. The board has also recently reviewed the terms of the authorisation for the product. As a result of this, revised wording for inclusion in the prescribing information for the product, outlining the current position regarding its use and warnings related to the possible development of psychiatric reactions, was agreed. The warnings refer to possible side effects including depression, psychotic symptoms and to rare reports of suicide associated with roaccutane. The revised warnings have been incorporated into the authorisation documents for the product and all physicians and pharmacists have been notified of the new warning regarding the use of roaccutane. Revised warnings have also been provided for in the package labelling and patient information leaflets. In addition, at the request of the IMB, the manufacturer has recently initiated a post-marketing surveillance programme to monitor all patient usage of roaccutane in Ireland. All data collected during this surveillance programme will be reviewed and analysed by the IMB and any further regulatory action required will be taken, as appropriate.

While I have not met with the group referred to by the Deputy, I understand that the Irish Medicines Board has advised representatives of RAGE about the board's active involvement with this drug. I am satisfied the board continues to actively monitor the safety profile of the product concerned and I am assured the board will take any action that may be necessary having regard to the risk-benefit ratio relating to the product.

Question:

233 Dr. Upton asked the Minister for Health and Children if his attention has been drawn to concerns regarding illegal and inappropriate use of the drug rohypnol; and if he will make a statement on the matter. [24424/99]

Flunitrazepam, which is the active ingredient in rohypnol, has been classified as a schedule three drug in this country since 1993. The drug was reclassified in 1993 in response to reports of misuse and its rescheduling makes it more difficult for drug misusers to get access to it. The regulations also require that doctors prescribing rohypnol abide by the special prescription writing requirements and rohypnol should be stored in a controlled drugs cabinet in accordance with the Safe Custody Regulations 1982. Under the terms of the Misuse of Drugs Acts 1977 and 1984 I may issue a special direction prohibiting prescribing by practitioners or pharmacists convicted of offences under these Acts.

Since rohypnol may only be obtained on foot of a prescription from a medical practitioner there is a need for a greater awareness among medical practitioners of the problems which can arise when rohypnol or other controlled drugs are prescribed in an inappropriate fashion. My Department's chief medical officer has written various letters to general practitioners concerning the need to exercise caution when prescribing controlled drugs. The most recent letter was issued on 30 August and specifically referred to the prescribing of benzodiazepines, into which drug category rohypnol falls.

My Department will continue to review the prescribing of rohypnol in consultation with the Irish College of General Practitioners and other specialist groups to determine whether action should be taken to curb the inappropriate use of rohypnol.

Top
Share