A woman died from liver failure as a result of an adverse reaction to a widely-used arthritis drug which was taken off the market earlier this month, an inquest heard yesterday.
Sheila Gunn, (69) of Donaghmeade Drive, Donaghmeade, Dublin, died on December 9th, 2005, of acute hepatic necrosis or liver failure and pneumonia caused by use of the drug Aulin at Beaumont Hospital, Dublin City Coroner's Court heard yesterday.
The coroner, Dr Brian Farrell, recorded a verdict of misadventure. He told the inquest he was satisfied Mrs Gunn's death was a result of an adverse reaction to Aulin and he would be reporting the matter to the Irish Medicines Board (IMB).
"This matter will form part of the discussion in relation to the marketing of this drug, which has been widely used in Ireland. It has been beneficial, but we have to be cognisant to adverse reactions, as we have heard today, in the public interest."
Aulin, a brand name of the drug nimesulide, a non-steroidal and anti-inflammatory drug, was recalled from the market by the IMB on May 15th, following concerns over adverse side effects.
Other brands of the drug, Mesulid and Mesine, were also recalled.
Dublin City Coroner's Court heard Mrs Gunn suffered from osteo-arthritis and secondary osteoporosis and had been attending a rheumatology clinic at the Mater hospital since July 2003. She was first prescribed Aulin for pain relief by her GP, Dr Tom Coughlan of Clannad Medical Centre, Kilbarrack, on May 19th, 2005 for pain relief.
Her usual dose was 100mg twice daily, the maximum dosage of the drug recommended by the IMB. Following an absence, she returned to see her consultant rheumatologist, Dr Conor McCarthy, on November 1st, 2005, and the results of standard tests carried out at the clinic showed significant liver dysfunction.
Dr McCarthy told the inquest: "I was aware she was on Aulin and of the effects." Dr McCarthy said he was not made aware of the results until November 17th and communicated them to Mrs Gunn's GP immediately by phone.
He told the inquest such test results are usually available on the same day and he would have expected to have been informed of the results more rapidly, considering the findings.
Dr Sarah Coughlan of Clannad Medical Centre informed Mrs Gunn of the results on the same day and said Mrs Gunn "was surprised" and informed her she was feeling well.
There was a lapse of five days and, following standard procedure, the tests were repeated on November 22nd and again indicated gross abnormal liver function.
Mrs Gunn was seen by Dr Frank Murray, a consultant gastroenterologist at Beaumont Hospital in the outpatients' department as an urgent referral on November 28th, with a "very marked hepatitis with severe jaundice" and was admitted to hospital on the same day.
Dr Murray told the inquest that "nimesulide was high on the list" of causes of Mrs Gunn's condition, but other possible causes had to be excluded, including possible obstruction of the bile duct, auto-immune hepatitis and viral hepatitis. Tests for those conditions were negative.
Mrs Gunn received supportive treatment for liver failure. On December 4th, her condition deteriorated and on December 9th, she died.
A spokeswoman for the IMB, Dr Joan Gilvarry, told the inquest that sale of nimesulide has been suspended in the State until a review of the drug has been completed. Aulin is marketed in 50 countries worldwide including 17 EU member states. It has never been sold in the UK or the US, but Dr Gilvarry said that is because the manufacturer of the drug, Helsin-Bayrex, has never applied for a licence to sell the drug in those countries.
Speaking outside the court, Mrs Gunn's daughter, Marcia O'Hagan said she was glad the sale of Aulin had been stopped "so no one can lose their mother. I miss my mother every day."
She said if her mother's case was instrumental in seeing the drug recalled worldwide, "that is what my mother would have wanted."
Since 1995, when nimesulide was first licensed in Ireland, 53 liver-related adverse reactions have been reported to the IMB.