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AULIN.... CLASS ACTION?!
16/05/2007 - Pain-killing drug linked to four deaths is withdrawn
THE national medicines watchdog was criticised yesterday for not banning earlier a pain-killing drug linked to four deaths from liver failure.
The drug failed to win approval in the United States and was banned in Spain and Finland.
But not until yesterday morning were over 30,000 people here told to stop taking the products Aulin, Mesulid and Mesine.
The advice came after the Irish Medicines Board (IMB) received reports that six people on the medication had to undergo liver transplants in St Vincent's Hospital, Dublin.
IMB medical director Joan Gilvarry urged people not to panic and advised them to go back to their doctors and return the drug to their pharmacist.
Around 30,000 people or more are prescribed the pain killers, which contain nimesulide, every month for treating acute pain, including from osteoarthritis, period pain and severe toothache. But the alert failed to reach many pharmacists and GPs who continued to issue prescriptions for the drug yesterday.
The board moved after receiving the results in recent days of an audit of liver-transplant patients carried out by doctors since 1994 in St Vincent's. The doctors told the board of six transplant cases, three of whom died, who were taking the drug.
The board was already aware of three other cases of liver failure, including of a patient who died, after taking the drug.
It had received 53 adverse reaction reports (related to the liver) about the drugs which are manufactured in Ireland by Helsinn Birex and Pinewood Healthcare.
Tony Hynes of Pinewood Healthcare, which produces the generic version, said yesterday they had begun a nationwide recall of stocks.
The drug, licensed here since the mid-1990s, was favoured because it was less likely than many similar drugs to cause bleeding ulcers.
Dr Majella Lane, an Irish-born pharmacist working in the University of London, questioned why the drug had been licensed here when reservations had been expressed at the time. She said concerns about its side-effects were not new.
However, Dr Gilvarry rejected criticisms of the IMB. It had fully monitored the drug over the years, she said. The risks of liver damage were extremely low and the drug was a very effective painkiller.
She said the first case of liver failure came to light in 1999 and the manufacturers were asked to do a safety study on 9,000 patients.
Doctors had been warned of the potential side-effects and the need not to give the drug to patients who had other risk factors for liver disease. "Ireland is one of fifty countries which licensed the drug," she said. It was not available in the UK because the manufacturers did not ask for a licence there.
A helpline (1-800-251054) has been set up.
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