A drug used by thousands of Irish patients was ordered to be withdrawn in the Republic yesterday after it was linked to liver failure in nine patients, three of whom have died. The drug is sold under brand names such as Aulin, Mesulid and Mesine.
A link between the drug and the death of a fourth patient from multiple organ failure has not been ruled out.
The Irish Medicines Board (IMB) ordered the recall and suspended the licence for medicinal products for oral use containing nimesulide, pending further investigation.
The drug is a non-steroidal anti-inflammatory used for severe osteo-arthritis and period pains, among other conditions
Patients on the drugs have been told to stop using them immediately and to seek medical advice as alternative medications are available.
The patients who suffered liver failure after using the drug did so between 1999 and 2007.
The IMB said while it was aware of the first case in 1999 it was not aware of all nine cases of liver failure until last week. The new information stemmed, it said, from an audit carried out at the National Liver Transplant Unit at St Vincent's Hospital in Dublin.
The audit was of all liver transplants carried out at the unit since 1999 and it found six transplants were on patients that had been taking nimesulide.
Dr Joan Gilvarry, director of human medicines at the IMB, said four of these cases of liver failure associated with this ingredient were new to the IMB and they "were the straw that broke the camel's back" and it was decided to withdraw it.
She rejected claims that the recall of the product had been haphazard. Some doctors continued to prescribe it yesterday unaware of the recall. She said letters had gone out to GPs and the public was immediately informed through the media.
The liver transplants, she said, which had been performed were in men and women ranging in age from their 20s to 60s.
The three deaths after liver failure occurred in 1999, 2006 and 2007. One of these cases appears to include the death of Joan Flavin (71), from Dungarvan, Co Waterford, whose inquest opened and adjourned just over a week ago. Two doctors testified at the inquest that they believed nimesulide caused the woman's death through liver failure. The coroner, Dr Myra Cullinane, said she wanted to hear the views of the IMB on nimesulide before concluding the inquest.
Dr Gilvarry said yesterday that liver failure was a very serious but rare side effect of the drug.
There are at least 30,000 prescriptions of it issued to medical card patients every month and thousands more issued to private patients.
Dr Gilvarry said the recent inquest had nothing to do with the IMB recall. Since nimesulide was first licensed in the State in 1995, a total of 53 liver-related adverse reaction reports have been reported to the IMB. This includes the nine cases of liver failure.
Dr Majella Lane, a lecturer in pharmaceuticals at the University of London, told RTÉ's Liveline programme yesterday that a one time member of the National Drugs Advisory Board (NDAB), the late Prof Graham Shaw, had indicated to her he had concerns about the licensing of the product in the first place.
But Dr Gilvarry said Prof Shaw was chair of the toxicology committee which was one of the committees that recommended to the board of the NDAB that the product should receive a licence. The NDAB preceded the IMB. The IMB has asked for a full safety review of nimesulide-containing products by the European Medicines Agency.
Patients with queries can contact the IMB on 1-800-251054 or 01-6343555.
Drugs assessment
What happens when a pharmaceutical company submits an application to the Irish Medicines Board (IMB) seeking to have a new drug approved for human use?
The company is obliged to submit data on the drug's quality, safety and efficacy to the IMB. This information is analysed by experts in pharmaceuticals, toxicology and medicine.
Pharmaceutical assessment involves a review of all the elements relating to the quality of the medicine. Toxicologists examine animal data to assess the drugs safety record when tested in animals. And the medical assessment focuses on information from clinical trials of the drug including information on how the new drug compares with placebo (dummy pill) or with an existing treatment for the disease. Ultimately the assessment is based on a benefit/risk model which takes into account the type of illness a new drug is designed to treat.
A cancer drug, for example, might be approved despite having significant side effects because it has been shown to prolong life. The final decision whether to grant a licence is made by the IMB's management committee.
How does the IMB monitor drugs that are on the market after they have been licensed?
Healthcare professionals and pharmaceutical companies notify the Board of suspected adverse reactions (ADR's) in patients. Drug companies must also submit, at regular intervals, periodic safety update reports (PSURs) on each product. These reports, compiled six monthly in the case of a new drug, include information on global adverse reaction data, information from new and ongoing studies of the drug and updated findings in the medical literature. The IMB publishes a detailed summary of product characteristics (SPC) for licensed medicines on its website which can be accessed by the public at www.imb.ie - Muiris Houston