Irish agency rejects European ruling on safety of painkiller

A commonly-used painkiller, taken off the market by drug regulators in the Republic last May because of links to liver failure…

A commonly-used painkiller, taken off the market by drug regulators in the Republic last May because of links to liver failure, has been declared safe following a review by the European Medicines Agency (EMEA).

However, the Irish Medicines Board (IMB) has strongly disagreed with the decision regarding nimesulide, saying it remains concerned about the safety of the anti-inflammatory drug.

The Irish Times understands the vote on the safety of nimesulide, marketed under the trade names Aulin, Mesulid and Mesine, was extremely close, with a number of countries, including Ireland, Germany and the Netherlands, coming together to publish a dissenting opinion on the matter.

Despite their concerns, if the decision by the EMEA is approved by the European Commission, the drug could be legally remarketed here later this year.


"The benefits of these medicines outweigh their risks, but there is a need to limit the duration of use . . . to ensure that the risk of patients developing liver problems is kept to a minimum," the EMEA said yesterday. It has decided to limit treatment with nimesulide to a maximum of 15 days.

However, Dr Joan Gilvarry, director of human medicines at the IMB, said: "Our concerns relating to the safety of nimesulide remain and we do not consider that the further restriction now proposed by the EMEA can ensure that nimesulide can be safely used."

Some six cases of liver transplantation performed because of liver failure linked to the drug were reported to the IMB earlier this year by the National Liver Transplant Unit in St Vincent's hospital, Dublin.

Those affected had been taking the drug for periods from one week to four months. The regulatory agency subsequently suspended the drug from the market here and, as it is obliged to do under EU law, referred its concerns to the EMEA, requesting a formal safety review.

While nimesulide and other anti-inflammatory drugs are known to cause mild elevation of liver function tests, these are usually reversible following withdrawal of the drug. Liver failure is the result of a rare idiosyncratic reaction to nimesulide.

Called fulminant hepatitis, the reaction causes widespread destruction of liver cells (necrosis). This process is irreversible, with liver transplantation the only possible treatment.

Liver disorders associated with nimesulide occur in less than one in 10,000 patients taking the drug, according to manufacturers.