Board suspends sale of certain anti-inflammatories

A prescribed drug was withdrawn from the Irish market today after three people died from liver failure.

Six other patients also needed liver transplants after taking nimesulide.

The Irish Medicines Board (IMB) ordered the suspension of the drug, which has not been approved in a number of other countries including the UK.

Nimesulide is a non-steroidal anti-inflammatory medicine used for the treatment of acute pain, the symptomatic treatment of painful osteoarthritis and period pains. It is available only on prescription.

Common brand names for the drug includes Aulin, Mesulid and Mesine.

The recall only applies to oral tablets and granules. Gels are not affected.

Patients taking these medicines are being warned to contact their pharmacist for advice.

IMB said it previously advised healthcare professionals that liver damage is a rare but serious side effect of the drug.

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 who needed life saving surgery at the National Liver Transplant Unit at St Vincent’s University Hospital, Dublin.

Three cases of liver failure resulted in a fatal outcome and the IMB is aware of one additional liver-related fatality.

“The IMB has notified the medicines regulatory authorities through Europe and has initiated a review of the safety of nimesulide containing products,” a spokesperson added.

The Irish Dental Association (IDA) has also advised all its members to discontinue prescribing or supplying the product to patients with immediate effect.

“In dental care the product typically associated with nimesulide is Aulin which is administered orally,” said an IDA spokesman.

“The product was only administered for cases of severe pain or inflammation. Dental patients requiring this product would have taken it on a short term basis and under the strict observation and advice of their family dentist.”

Darragh O’Loughlin, a pharmacist from Galway and member of the Irish Pharmaceutical Union (IPU) said patients all over Ireland are taking nimesulide for conditions such as arthritis and other inflammatory problems.

“They will be concerned to hear that nimesulide is now being withdrawn because of reports of liver damage,” he said.

“We would advise these patients to stop taking the medicines immediately and contact their local pharmacist or GP to discuss their concerns and find out what they need to do. We would also advise patients to return any nimesulide that they may have to their local pharmacy.”

The IPU represents 1,600 community pharmacists.