CHMP initiates safety review of nimesulide drugs

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has started a review of the formulation of nimesulide-containing medicinal products due to concerns over serious liver problems. This follows an earlier suspension of the marketing authorizations in Ireland for all nimesulide-containing products by the Irish Medicines Board (Marketletter May 21). These products containing nimesulide are approved in a number of European Union member states for the treatment of acute (short-term) pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhea (period pains).