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Medsafe Orders Osteoarthritis Drug Withdrawal

Medsafe Orders Osteoarthritis Drug Withdrawal

A review of the latest safety data on the osteoarthritis drug Prexige (lumiracoxib) has resulted in Medsafe withdrawing approval for the medicine and requiring the company that markets it to remove the product from the New Zealand market.

Medsafe's Medicines Adverse Reactions Committee (MARC) reviewed new safety data for the medicine at its December meeting. The committee noted that new data reporting the occurrence of liver damage following prolonged use of low doses of lumiracoxib had been provided and recommended that Medsafe reconsider the availability of this medicine once a decision by the European Medicines Evaluation Agency was released.

The European Medicines Evaluation Agency assessment, released on Friday December 14, stated the risk of liver damage associated with the use of lumiracoxib outweighed any potential benefits the medicine had to offer and recommended that products containing lumiracoxib be withdrawn from the European market. Medsafe agrees with this assessment and has today published a notice in the New Zealand Gazette revoking the consent for this medicine.

In August Medsafe revoked consents for the supply of 200mg and 400mg tablets of lumiracoxib. This decision was made after Medsafe and the MARC reviewed local and international safety data for lumiracoxib relating to reports of severe liver damage in patients using this medicine at doses of 200mg and above.

At that time the MARC recommended that the 100mg dose of lumiracoxib be restricted to patients with osteoarthritis and that patients on this medicine also have monthly blood tests. This risk management plan significantly reduced the use of lumiracoxib in New Zealand. There have been no reports of serious liver damage occurring in patients taking low dose lumiracoxib in New Zealand and Medsafe understands that less than 200 patients are currently using this medicine.

Patients currently taking lumiracoxib, who are unwell with nausea, vomiting, loss of appetite, stomach pains, dark urine, yellowing or itching of the skin, should stop taking the medicine and see their doctor. If they are well, but worried about taking this medicine, they should see their doctor before their next scheduled visit. Medsafe advises that patients and their doctors consider an alternate medicine at the next scheduled visit.

Dr Andrea Forde, Acting Principal Technical Specialist at Medsafe

ENDS

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