In June 2007, HSA suspended the local sales of nimesulide-containing oral preparations pending the safety review of nimesulide following both local and overseas signals of liver toxicities. Nimesulide, non-steroidal anti-inflammatory drug, is indicated for the treatment of acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea.

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) was tasked to review the safety profile of nimesulide following the suspension of nimesulide in Ireland in May 2007 due to concerns with liver toxicities. CHMP concluded in September 2007 that nimesulide is associated with an increased risk of liver toxicity. However, the committee recommended that nimesulide could still be marketed in the European Union but with strict restrictions imposed on the use of the drug: nimesulide should not be prescribed to patients with compromised liver function nor patients prescribed other medicines that can also cause liver damage, and to limit the treatment with nimesulide to a maximum of 15 days.

HSA completed the review of available data, which comprised of local adverse drug reaction reports, the WHO international adverse drug reactions database, literatures, EMEA's review and local consumption data of the product in December 2007. The review concluded that:

• Nimesulide is associated with an increased risk of liver toxicity, though the incidence is rare, and there is no clear elucidation of the mechanism of action. 
  
• The risks versus benefits profile of nimesulide is unfavourable in view of the presence of isolated cases of liver injuries associated with nimesulide in Singapore, the inability to identify patients who might be at risk, and the difficulty in implementing restricted use of nimesulide in the local context.
  
• There are alternative treatment options available for treating the conditions that nimesulide is indicated for.

Hence, the sales of oral preparations containing nimesulide will remain suspended and the product licences of Nidol® tablet, Nidol® satchet, Nimotas-CD® Ttablet, Nise® tablet and Qnim MD® tablet will not be renewed upon expiry. Effectively, this means that no marketing of nimesuilde has been authorised by HSA since June 2007.

HSA has posted a Dear Healthcare Professional Letter to inform all healthcare professionals of this decision on 26 December 2007 in the Health Professionals Portal. For details of the letter, please log onto the portal at http://www.hpp.moh.gov.sg