Vol. 505 No. 4
120 Mr. Gormley asked the Minister for Health and Children the reason explicit label warnings in relation to psychiatric side effects of Roaccutane were featured on packaging in France, United States of America and other countries since the mid 1980s and in Ireland until 1988; and if he will make a statement on the matter. [13994/99]
I refer the Deputy to extensive replies which I gave to the House in response to questions on 22 April 1999 in relation to this product.
This product has been the subject of a product authorisation since 1983 and, as with all medicinal products, was subject to ongoing review by the former National Drugs Advisory Board. As I previously explained, a full review of the relative safety and efficacy of this product was carried out by the newly established Irish Medicines Board as part of the assessment of the renewal of the authorisation in 1998 and also as a result of information regarding the development of neuropsychiatric reactions, including depression, suicide and suicide ideation, reported in connection with the use of the product.
As a result of this review, the prescribing data and patient information leaflets were amended in 1998 to reflect the latest information becoming available in relation to possible side effects associated with the product, including possible neuropsychiatric reactions.
