More than five million treatments of pain drug Nimesulide were prescribed in Ireland before it was suspended on 15 May 2007 – but questions have been asked about this drug as early as 1999.
Why was the drug left on the market for so long, when other countries banned it? The article below explores the timeline of Nimesulide and what was known about it’s potentially fatal side effects.
1995 – Nimesulide is authorised in Ireland by the Irish Medicines Board (IMB).
1999 – The IMB notifies the World Health Organisation (WHO), the directing and coordinating authority for health within the United Nations, that there are potential for Hepatic (Liver) adverse side effects in patients who have taken Nimesulide. The notification also includes reference to recent reports of serious Hepatic events including rare cases of fatalities in patients who were treated with the drug throughout the world. As a result, the prescribing information for Nimesulide is amended as follows:
A Contraindication is a condition which makes a particular treatment or procedure inadvisable. It is no longer considered appropriate to treat patients who have Hepatic (Liver) Impairments with Nimesulide.
It is also advised that patients with a history of peptic ulcers, recurrent ulcerations or gastrointestinal bleeding should NOT be treated with Nimesulide.
2002 – In July, the Irish Medicines Board (IMB) Newsletter (15th Edition) indicated the following:
“The potential for hepatic adverse effects following exposure to Nimesulide has been an ongoing concern to the IMB for some time. We previously reviewed the safety of Nimesulide in 1999 and updated the prescribing information at the time to reflect concerns regarding Hepatotoxicity”. Hepatoxicity means poisonous to the liver.
In addition, the newsletter stated:
“Recently, concerns with hepatotoxicity have also been discussed at European level, which have led to a reassessment of the overall benefit/risk profile of Nimesulide. The IMB is actively involved in this review and any further regulatory changes considered necessary will be implemented and notified when the review has been completed. The IMB is aware that marketing of Nimesulide has been suspended in a number of countries (Finland, Spain and Turkey), pending the outcome of the review”.
“The IMB advises prescribers to be aware of Nimesulide’s potential for Hepatotoxicity, to adhere strictly to the prescribing information and to report any suspected events in the usual way, in order to facilitate monitoring of the safety of the product”.
2003 – The Irish Medicines Board (IMB) Newsletter (17th Edition) once more outlines the IMB’s concerns regarding Nimesulide:
“The IMB is aware that marketing of Nimesulide has been suspended in Finland and Spain pending the outcome of the review. This withdrawal in a number of countries prompted the Spanish regulatory authority to compare the risks of hepatotoxicity associate with various non-steroidal anti-inflammatory drugs (NSAIDs) marketed in Spain during the 1990’s. The result of this study indicated that Nimesulide had a higher risk of hepatotoxicity than comparators and in addition, Nimesulide reactions were more severe”. To date, the IMB has received a total of 18 reports of Hepatotoxicity suspected and associated with Nimesulide. 2 of these cases resulted in a fatal outcome”.
Also in July 2003, the British Medical Journal (BMJ) publishes an article relating to a study into the Hepatic (Liver) consequences of Nimesulide:
“A study by Giuseppe Traversa and others has been fast tracked because its status should help drug regulatory authorities decide whether to ban Nimesulide (an Non-Steroidal Anti-Inflammatory drug or NSAID). The drug is banned in Finland and Spain because of Hepatotoxicity, but it’s the most commonly used NSAID in Italy. Authorities are deciding now whether to ban the drug”.
15 May 2007 – The Irish Medicines Board announces the suspension of the marketing and sale of ALL PRODUCTS CONTAINING NIMESULIDE. Nimesulide is marketed in Ireland under the names Aulin, Mesulid and Mesine. Patients are asked to stop taking the drug immediately, return their packets of Nimesulide to their pharmacist and consult their GP for further advice.
It is clear that there was evidence available to the IMB since 1999 which indicated the adverse side effects associated with Nimesulide. An issue arises as to whether the Irish Medicines Board has fulfilled their statutory obligations in protecting the Irish public from the consequences of Nimesulide.
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