Joint Pain Forum – News you can use!
Arthritis drug withdrawn after fatalities
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
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
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:
· Aulin 100mg Tablets (PA 294/18/1)
· Aulin 100mg Granules (PA 294/18/2)
· Mesulid 100mg Granules (PA 915/1/1)
· Mesulid 100mg Tablets (PA 915/1/2)
· Mesine 100mg Tablets (PA 281/111/1)
· Aulin 100mg Tablets (PPA 465/110/1)
· Aulin 100mg Granules (PPA 1328/51/1)
· Aulin 100mg Tablets (PPA 1328/51/2)
Further information is available on the
IMB website at www.imb.ie .
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