Withdrawal of lumiracoxib

admin December 14th, 2007

EMEA have withdrawn lumiracoxib from the European market due to its effects on the liver [PDF]:

The liver safety of lumiracoxib has been monitored continuously since its launch in 2005. In August 2007, the product information was updated with contraindications for patients with potential liver problems and advice to doctors that they should frequently monitor patients treated with lumiracoxib for liver reactions. More spontaneous reports of serious liver problems have been received since then, which have increased the concerns regarding hepatic safety for lumiracoxib. In addition, the CHMP considered that the proposed measures to reduce the risk for liver reactions can not assure adequate patient safety, and are not considered realistic given the approved clinical indication.

Consequently, the CHMP is now recommending the withdrawal of the marketing authorisations.

EMEA have issues a Q&A [PDF], including the following points:

What are the recommendations for patients and prescribers?

  • Patients who are currently taking lumiracoxib and have signs of possible problems with their liver should see their doctor immediately. The signs to watch out for are: feeling sick; vomiting; loss of appetite; tiredness; stomach pains; dark urine; itching; or yellowing of the skin.
  • Patients who are currently taking lumiracoxib and who are feeling well should make an appointment to see their doctor as soon as is convenient, so that the doctor can change their prescription.
  • Doctors should stop prescribing lumiracoxib. Alternative treatments should be used as appropriate, based on each patient’s symptoms and individual risk profile.

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