Helpline gets 1,000 calls after drug is withdrawn

A helpline set up by the Irish Medicines Board (IMB), following its recall of a widely used anti-inflammatory drug, has received…

A helpline set up by the Irish Medicines Board (IMB), following its recall of a widely used anti-inflammatory drug, has received almost 1,000 calls in its first two days in operation.

Two of the callers reported adverse reactions to the drug which is called nimesulide and is sold under brand names such as Aulin, Mesulid and Mesine. Their cases were not previously reported to the IMB and they were advised to see their GPs.

The drug was ordered off shelves by the IMB on Tuesday, after it was linked to liver failure in nine patients, three of whom have died. And a link between the drug and the death of a fourth patient from multiple organ failure has not been ruled out.

Dr Joan Gilvarry, director of human medicines with the IMB, defended her organisation's decision not to order the withdrawal of the drug at an earlier stage.

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The drug was withdrawn in Finland and Spain in 2002 after it was linked to liver failure in a number of patients.

Dr Gilvarry said a Europe-wide review of the drug followed the decision of the Finns and an EU scientific committee concluded the benefits of the drug outweighed the risks. She added that the drug was still licensed in 50 countries worldwide, including 17 European states. These include France, Austria, Belgium, Italy and Luxembourg.

Dr Gilvarry said the IMB acted this week after receiving the results of a new audit carried out at the National Liver Transplant Unit at Dublin's St Vincent's hospital. This found six of its transplants since 1999 had been on patients who had been taking nimesulide. Four of these cases of liver failure associated with the drug were new to the IMB and it acted immediately, she said.

The drug is prescribed to thousands of patients every month for arthritis, back ache, period pain, toothache and other conditions.

The IMB helpline number is 1-800-251054.