Vol. 491 No. 3
287 Mr. Stanton asked the Minister for Health and Children his views on the safety of the medication known as roaccutane; the action, if any, he intends to take with regard to alleged side effects; and if he will make a statement on the matter. [11904/98]
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. Its availability is limited in that it must be prescribed and its use monitored by a specialist dermatologist. The current data sheet on the product contains the warnings that mood swings may occur, including precipitation of depression.
The Irish Medicines Board has been actively monitoring data on roaccutane which it has reviewed both internally with experts and with the other European regulatory agencies. In addition, it has also reviewed the matter with the company and has now finalised 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. The warnings will refer to possible side effects, including depression, psychotic symptoms and rarely suicide having been reported with roaccutane. The revised warnings are currently being incorporated into the authorisation documents for the product and the company will within the next week circularise all physicians and pharmacists outlining the new warnings regarding the use of roaccutane. As with all medicines, it is important that patients should read carefully any information and follow any instructions provided with the medication and consult with their physicians in relation to any problems, side effects or uncertainties they may encounter.
