Urgent advice regarding management of patients taking lumiracoxib (Prexige)

Safety alert

13 August 2007

• ALL patients should stop taking Lumiracoxib immediately.
• ALL patients should be assessed by their doctor for any clinical or biochemical evidence of liver damage.

Lumiracoxib (tradename Prexige) was approved for the indications:

• Symptomatic relief in the treatment of osteoarthritis.
• Relief of acute pain, including post-operative pain and pain related to dental procedures.
• Relief of pain due to primary dysmenorrhoea.

First approved in Australia in July 2004 lumiracoxib had recently become widely used since being PBS-listed in mid-2006.

As of 10 August 2007, the TGA had received eight reports of serious liver adverse reactions associated with use of lumiracoxib, including two deaths and two patients requiring liver transplants. All these reports have been received since March 2007, with 6 reports received in the last 6 weeks. The TGA has urgently investigated these reports and as a result has acted to deregister the drug to prevent further cases of liver damage related to lumiracoxib.

Although there is limited data on the natural history of the hepatic side effects of lumiracoxib, the pre-registration clinical trial data suggested that if a patient developed elevated liver function tests while on the drug, they were likely to normalise their biochemistry when the lumiracoxib was ceased.

However, in the 8 serious Australian reports studied, some patients have not improved on cessation of the medicine, due to the severity of the hepatic injury.

It is therefore advisable that all patients cease taking lumiracoxib immediately, and are assessed by their doctor for any clinical or biochemical evidence of liver damage.

Medical practitioners are advised to contact as a matter of urgency their patients who have been prescribed lumiracoxib to arrange clinical assessment and biochemical testing of liver function where indicated. Those patients with liver function abnormalities should be referred for specialist hepatologist review and further investigated as required.

All sample packs of Prexige in your possession should be returned to your Novartis sales representative; none should be distributed.

The TGA has established an Information Line at 1800 004 599 for patients and healthcare professionals.

The sponsor, Novartis Pharmaceuticals, have also established an information line at 1800 671 203.

Your assistance in following up your patients who may have taken lumiracoxib is greatly appreciated.

Dr Rohan Hammett
Principal Medical Adviser
Therapeutic Goods Administration
13 August 2007

Also see

• Medicines Regulator cancels registration of anti inflammatory drug, Lumiracoxib (Prexige)
  media statement, 11 August 2007
• Medicine recall notice: Lumiracoxib (PREXIGE)
  10 August 2007