The Swiss company behind the drug ingredient suspended by the Irish Medicines Board (IMB) vowed to defend its position but would not comment on the future prospects of its plant at Mulhuddart in Dublin, which makes the product in question.
Helsinn employs some 220 manufacturing and sales staff at the Mulhuddart plant, whose main product nimesulide was suspended by Irish regulators yesterday and referred to the EU Committee for Human Medicinal Products.
Nimesulide is used in drugs for the treatment of acute pain, osteoarthritis and dysmenorrhoea. Helsinn said the product was authorised in more than 50 countries and had been used by some 500 million patients worldwide since 1985.
"Nimesulide has been sold in Ireland under prescription since 1995 and in this period an estimated five million treatments have been prescribed."
A Helsinn spokesman in Lugano said the firm believed it would be able to confirm the safety of the product and said its profile was in line with comparable non-steroidal anti-inflammatory medicine. He declined to comment on what would happen to the Irish plant if the review of nimesulide led to its formal withdrawal from the market.
Helsinn said in a statement that it shared the concern of the IMB for the safety of the Irish public and was co-operating fully with the review.
"The use of nimesulide has been already reviewed by the European Medicines Agency in 2003, confirming the positive benefit/risk profile when used in accordance with prescribing instructions. Helsinn will work with the IMB and the EU authorities to ensure a full comprehensive review of all the safety data is completed as soon as possible. This is particularly important because the clinical details of the cases have not been disclosed."
