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Dáil Éireann debate -
Tuesday, 23 Mar 1999

Vol. 502 No. 3

Written Answers. - Medicinal Drugs.

Richard Bruton

Question:

340 Mr. R. Bruton asked the Minister for Health and Children if his attention has been drawn to the side effects of Roaccutane and the request for an independent inquiry into the matter; and if he will make a statement on the matter. [7881/99]

I am aware of reports of certain adverse reactions in relation to Roaccutane, including reports suggesting possible linkages between this product and depression, including suicidal tendencies. 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 specialist dermatologist.

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 experts and with the other European regulatory agencies. In addition, the board has also recently reviewed the terms of the authorisation for the product with the company. 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 of rare reports of suicide associated with Roaccutane. The revised warnings have been incorporated into the authorisation documents for the product and the company has circularised all physicians and pharmacists outlining the new warnings regarding the use of Roaccutane.

Whilst I am aware of recent calls for an independent inquiry into the matter of adverse reactions to Roaccutane, I do not consider it necessary for me to establish or carry out any such inquiry into the matter, particularly as the Irish Medicines Board, an independent statutory body with a specific remit in this area, is already engaged in monitoring those adverse reactions reported to it.

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