Arthritis Drug Withdrawn From Sale
A prescription drug has been withdrawn from sale following liver failure in nine people, three of whom died. The osteoarthritis drug Nimesulide, also known as Aulin and Mesulid, was ordered to be taken off the shelves by the Irish Medicines Board.
Since the drug’s introduction to the Republic 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.
Nimesulide is a non-steroidal anti-inflammatory medicine used for the treatment of acute pain, the symptomatic treatment of painful osteoarthritis and for primary dysmenorrhoea.
The IMB now says that liver damage is a rare but serious adverse effect known to occur with Nimesulide and it has now been provided with information from the National Liver Transplant Unit at St Vincent’s University Hospital on six patients who required liver transplant following treatment with the drug.
The IMB has notified the medicines regulatory authorities throughout Europe of this new data and initiated a referral for a full safety review of nimesulide containing products by the European Medicines Agency (EMEA).
The products being withdrawn are Aulin 100mg Tablets, Aulin 100mg Granules, Mesulid 100mg Granules, Mesulid 100mg Tablets, Mesine 100mg Tablets, Aulin 100mg Tablets and Aulin 100mg Granules.
Patients and healthcare professionals who have any queries can contact the IMB on: Freephone 1800-251054 or 01-6343555.