Vol. 494 No. 6
104 Ms McManus asked the Minister for Health and Children if his attention has been drawn to any side effects associated with the drug Asacolon in relation to kidney failure; and if he will make a statement on the matter. [18993/98]
The medicinal product Asacolon is authorised by the Irish Medicines Board in accordance with the provisions of the Medicinal Products (Licensing and Sale) Regulations, 1998. It is indicated for the treatment of ulcerative colitis, proctitis and proctosigmolditis.
The prescribing data issued in relation to the product, as agreed with the board, includes a special warning that the product should be used with great caution in patients with renal dysfunction. Among the side effects reported in relation to the products and noted in the prescribing data sheets are reports of nephrotic syndrome and renal failure with oral treatment. The prescribing data also indicates that nephrotoxicity should be suspected in any patients on this medication who develop renal failure during treatment.
As with all medicinal products, reports of adverse reactions are continually monitored by the Irish Medicines Board and any action that might be considered appropriate as a result of any such reports, and having due regard to risk-benefit ratios, would, of course, be taken.
