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Published on 14 December 2007

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EMEA withdraws lumiracoxib from EU

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The European Medicines Agency (EMEA) has recommended withdrawing the marketing authorisations for all medicines containing lumiracoxib.

The regulator believes the drug carries a risk of serious side-effects affecting the liver.

Lumiracoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group COX-2 inhibitors, and is used in the treatment of osteoarthritis of the hip and knee.

The EMEA’s Committee for Medicinal Products for Human Use (CHMP) concluded the risks of lumiracoxib-containing medicines are greater than their benefits after examining study data.

The Europe-wide review was started on 15 November following reports of serious liver damage by patients in the UK.

The UK has already suspended its marketing authorisation, and similar moves were taken in Germany, Cyprus and Belgium.

The safety of lumiracoxib has been monitored closely since its launch in 2005, and in August this year doctors were urged to regularly assess patients taking it for liver problems.

But more reports have now been received of issues surrounding the drug, leading the CHMP to make the decision to withdraw it.

Patients taking lumiracoxib are being urged to seek medical advice as they may need to change to other medications.

Copyright © PA Business 2007

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