Medicines containing nimesulide in systemic formulations are authorised in a number of European Union (EU) Member States to treat acute pain, and the symptoms of painful osteoarthritis and primary dysmenorrhoea (period pains).
The marketing authorisations for nimesulide-containing medicines were suspended by the Irish competent authority in Ireland on 15 May 2007, because of reports of serious side effects affecting the liver. After the Irish authority had notified the EMEA about the suspension, the Committee for Medicinal Products for Human Use (CHMP) started an assessment of the hepatic safety of these medicines in June 2007 to reach a conclusion on whether the regulatory actions taken by Ireland should be implemented throughout the EU.
Having considered all of the available evidence, the CHMP concluded that the data did not support a suspension of all marketing authorisations in Europe. However, it also concluded that there was a need for the marketing authorisations to be changed, with the information provided to doctors and patients to be amended to limit the risk of liver injury.
The CHMP therefore recommended that treatment with nimesulide should be limited to a maximum of 15 days and that consequently all packs containing more than 30 doses (tablets or sachets) should be removed from the market. Doctors are advised to base their decision to prescribe nimesulide on an assessment of the individual patient's overall risks.
A European Commission Decision on this opinion will be issued in due course. The Decision will apply in all Member States.
The European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The EMEA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit one single marketing authorisation application to the EMEA. For further information, visit www.emea.europa.eu.