Dáil Éireann debate -
Thursday, 30 Sep 1999

Vol. 508 No. 2

Written Answers. - Roaccutane Regulation.

Brian O'Shea

Question:

62 Mr. O'Shea asked the Minister for Health and Children the investigations, if any, carried out to establish the safety of the drug Roaccutane in view of another possible suicide which may have been linked to the drug; if he has satisfied himself that safety warnings carried on labels are adequate; and if he will make a statement on the matter. [18249/99]

Minister for Health and Children (Mr. Cowen)

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. I am aware that there have been reports in the past of possible adverse reactions to the drug, including reports of possible suicides linked to its usage.

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. 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 was 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. In addition revised warnings have also been provided for in the package labelling and patient information leaflets.

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 ratios relating to the product.