EMEA recommends withdrawal of the marketing authorisations for lumiracoxib-containing medicines

The European Medicines Agency (EMEA)The European Medicines Agency (EMEA) has recommended the withdrawal of the marketing authorisations for all lumiracoxib-containing medicines, because of the 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'. It is used for symptomatic relief in the treatment of osteoarthritis of the hip and knee.

Finalising a review of available information on the safety of lumiracoxib, which concentrated on worldwide data on liver side effects, the Agency's Committee for Medicinal Products for Human Use (CHMP) concluded at its December 2007 meeting that the risks of lumiracoxib-containing medicines are greater than their benefits. The CHMP therefore recommended that the marketing authorisation for these medicines should be withdrawn in all European Union (EU) Member States where they are approved.

The Europe-wide review was started on 15 November 2007 following assessment of reports of serious liver injury by the United Kingdom. The CHMP was asked to give a scientific opinion on whether the marketing authorisations for lumiracoxib should be revoked (withdrawn), suspended or changed across the EU. On 19 November 2007 the United Kingdom suspended the marketing authorisation of this medicine. Similar regulatory action was taken in Germany, Cyprus and Belgium.

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.

Patients taking lumiracoxib-containing medicines should contact their doctor as they may need to change to other medicines if there is a need for treatment.

The CHMP's opinion will now be forwarded to the European Commission for the adoption of a decision.

For further information, visit www.emea.europa.eu.

Most Popular Now

OPKO and Pfizer announce positive Phase 3 top-line…

OPKO Health Inc. (NASDAQ: OPK) and Pfizer Inc. (NYSE: PFE) announced that the global Phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with g...

Amgen recommends rejection of 'mini-tender' offer …

Amgen (NASDAQ:AMGN) today announced that it has been notified of an unsolicited "mini-tender" offer dated Oct. 11, 2019, made by TRC Capital Corporation, a private Canadi...

Researchers find new signaling systems in human ce…

The human cell has a wide variety of receptors on its surface that many molecules and therapeutic drugs can bind to in order to activate signals inside the cell to regula...

Rare diseases: Over 300 million patients affected …

Rare diseases represent a global problem. Until now, the lack of data made it difficult to estimate their prevalence. Created and coordinated by Inserm, the Orphanet data...

Bed time is the best time to take blood pressure m…

People with high blood pressure who take all their anti-hypertensive medication in one go at bedtime have better controlled blood pressure and a significantly lower risk ...

One avocado a day helps lower 'bad' cholesterol fo…

Move over, apples - new research from Penn State suggests that eating one avocado a day may help keep "bad cholesterol" at bay. According to the researchers, bad choleste...

Boehringer Ingelheim advances first pan-KRAS inhib…

Boehringer Ingelheim presented promising preclinical data from its pan-KRAS program including the novel, oral inhibitor BI 1701963 at the AACR-NCI-EORTC International Con...

Rare diseases: Over 300 million patients affected …

Rare diseases represent a global problem. Until now, the lack of data made it difficult to estimate their prevalence. Created and coordinated by Inserm, the Orphanet data...

Synthetic phages with programmable specificity

Bacteriophages ("phages" for short) are viruses that infect bacteria. Phages are highly host-specific and will typically only infect and kill an individual species or eve...

Cannabis could help alleviate depression and suici…

Cannabis may be helping Canadians cope with the effects of post-traumatic stress disorder (PTSD), new research suggests. In an analysis of health survey data collected by...

AstraZeneca divests rights to Seroquel and Seroque…

AstraZeneca has agreed the sale and licence of the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended rel...

Attacking metastatic breast cancer with sound

Drugs can be safely delivered to cancerous lymph nodes via the lymphatic system and then released inside the nodes using sound waves. Tohoku University researchers tested...