Arthritis drug caused liver failure, inquest hears

A COMMON drug used in Ireland to ease arthritis pain was linked yesterday to acute liver failure in an elderly widow who died last year.

Two medical experts told the inquest into the death of Joan Flavin, aged 71, from Windygap, near Dungarvan, Co Waterford, that they believe the compound, Nimesulide — prescribed by her GP eight months before her death last September — was responsible.

Although a rare occurrence, the drug does have liver toxicity issues, Cork Coroner’s Court was told.

Consultant Orla Crosbie, a leading specialist in liver disease based at Cork University Hospital (CUH), and consultant surgeon, Mr Criostóir Ó Súilleabháin, based at the city’s Mercy University Hospital (MUH), both said they have reported the circumstances of Mrs Flavin’s death to the Irish Medicines Board (IMB).

The inquest was told that the drug, which failed to get Food and Drug Administration (FDA) approval in the US, is not marketed in America, New Zealand, Australia or in Scandinavian countries.

The Flavin family’s solicitor, Paddy Golden, told the court that it has also been withdrawn from sale in Portugal, Sri Lanka and France.

Mr Golden tried to introduce evidence from the IMB in relation to the drug, but City Coroner Dr Myra Cullinane would not allow its introduction because she had not been furnished with the evidence before the inquest.

She rose to consider the document and later resumed the hearing, adjourning the inquest until May 31 on her return.

She plans to call an expert IMB witness to give independent evidence on that date to clarify the risk profile of Nimesulide.

The inquest heard how Ms Flavin, who had osteoarthritis, had knee joint replacement surgery in February 2005.

Her local GP, Dr Tom Higgins, changed her pain medication in February 2006 and prescribed Nimesulide.

One of Ms Flavin’s daughters, Christine Power, told the inquest that her mother was not on any other medication at the time and felt great on the new drug.

But several months later, and following a number of weeks of feeling unwell, Ms Flavin returned to Dr Higgins on August 16, 2006, complaining of stomach pain and nausea. She was also jaundiced.

He admitted her later that day as an acute patient to MUH.

Mr Ó Súilleabháin reviewed her the next day, ruled out gall stones and following a barrage of tests, including a liver biopsy, diagnosed acute liver failure.

“We felt liver failure was due to the drug. All other causes had been ruled out,” he said.

He contacted Professor Aiden McCormick at the National Liver Transplant unit at St Vincent’s Hospital in Dublin, but Mrs Flavin’s age ruled her out as a suitable transplant candidate.

Ms Flavin was transferred to CUH on September 1 where aggressive medical treatment continued under Dr Crosbie.

She said Nimesuline has “a good side-effects safety profile” but that in some cases, there can be an idiosyncratic, or unexpected reaction, to the drug.

But she added that it was very likely that the drug caused Ms Flavin’s liver failure.

Despite constant dialysis, Ms Flavin’s condition never improved and she died on September 10, 2006.

The inquest, which is being heard before a jury of four men and two women, will resume on May 31 at which time the IMB will present its evidence.

Assistant State pathologist, Dr Margaret Bolster will also give evidence on the exact cause of death to the inquest.