IMB suspends sale of nimesulide products

The Irish Medicines Board has suspended the marketing and sale of nimesulide-containing drugs for oral use available in Ireland. The compound is a non-steroidal anti-inflammatory authorized in Ireland since 1995 for the treatment of acute pain, the symptomatic treatment of painful osteoarthritis and for period pains. It is available only on prescription. Liver damage is a rare but serious adverse effect known to occur with nimesulide and the IMB has now been provided with information from the National Liver Transplant Unit at St Vincent's University Hospital on six patients who required liver transplant following treatment. Three cases of liver failure resulted in a fatal outcome and the IMB is aware of one additional liver-related fatality. It consequently notified drug regulatory authorities throughout Europe and has initiated a review of the safety