Irish people using a drug used to treat chronic osteoarthritis pain have been warned to immediately stop taking it after it was found a small number of patients prescribed the drug suffered fatal liver failure.
The Irish Medicines Board today announced the suspension of the marketing and sale of medicinal products containing nimesulide for oral use pending a safety review of the drug at European level.
Nimesulide is a non-steroidal anti-inflammatory medicine authorised in Ireland since 1995 for the treatment of acute pain, the symptomatic treatment of painful osteoarthritis and for period pains, according to the IMB. It is available only on prescription.
The IMB said it had now been provided with information from the National Liver Transplant Unit at St Vincent's University Hospital on six patients who required a liver transplant after treatment with nimesulide.
"Liver damage is a rare but serious adverse effect known to occur with nimesulide and the IMB has previously issued advice to healthcare professionals regarding this risk," the IMB said in a statement.
"Since nimesulide was first licensed in Ireland in 1995, a total of 53 liver-related adverse reaction reports have been received.
"This includes nine cases of liver failure, six of which originated from the National Liver Transplant Unit. Three cases of liver failure resulted in a fatal outcome and the IMB is aware of one additional liver-related fatality," the statement added.
The IMB said it has notified the medicines regulatory authorities through Europe of this new data and initiated a referral for a full safety review by the European Medicines Agency (EMEA) of products containing nimesulide.
It advised patients to stop taking the medicine immediately and to return to their doctors for a review of their condition and further advice.
Any remaining packs (either used or partially used) of the drug should be returned to the patient's pharmacist.
The IMB said it is working to inform all patients, doctors, and pharmacists of this issue and has instructed the relevant companies to recall their products from all patients/consumers, pharmacies, hospitals and wholesalers immediately.
The affected products and their marketing authorisation numbers are:
Further information is available on the IMB website at www.imb.ie.
Patients and healthcare professionals who have any queries may also contact the IMB on the following helpline numbers: Freephone 1-800-251054 or 01-6343555.