Dáil Éireann debate -
Thursday, 27 May 1999

Vol. 505 No. 5

Written Answers. - Medicinal Products.

John Gormley

Question:

57 Mr. Gormley asked the Minister for Health and Children the plans, if any, he has to withdraw the licence for the sale of Roaccutane pending the completion and publication of independent studies on the chemical changes in the brain induced by the drug and in view of the high levels of suicide and para-suicides linked to this drug; and if he will make a statement on the matter. [13988/99]

Minister for Health and Children (Mr. Cowen)

Under the Irish Medicines Board Act, 1995, the Irish Medicines Board is the statutory authority for the licensing of medicinal products, including Roaccutane and the question of a withdrawal of the authorisation for this product is entirely a matter for the board.

However, I am advised that the availability of the product, which is intended for the treatment of severe forms of acne unresponsive to other treatments, is limited in that it must be prescribed and its use monitored by a consultant dermatologist. In addition, in recent years both the prescribing data for physicians and the patient information leaflet have been strengthened with additional warnings as to possible reactions, including suicide and suicide ideation, associated with the product. In these circumstances, the Irish Medicines Board does not consider it necessary to withdraw the authorisation for the product at this time.

However, as with all medicinal products, the board continues to monitor the safety of the product and, in line with its statutory responsibilities, will take whatever action in relation to the product as it may deem necessary.