Dan Neville
Ceist:174 Mr. Neville asked the Minister for Health and Children if his Department has completed tests on the drug Roaccutane in view of the deaths of two teenagers from suicide after having been treated with the drug. [23115/99]
Written Answers. - Medicinal Products.
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, 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 United Kingdom 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 were 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.
I am satisfied that the board continues to actively monitor the safety profile of the product and I am assured that it will take any action that may be necessary having regard to the risk-benefit ratio relating to the product.