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 The CHMP therefore recommended that the marketing authorisation for these medicines should be withdrawn in all European Union (EU) Member States where they are approved.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CHMP was asked to give a scientific opinion on whether the marketing authorisations for lumiracoxib should be revoked (withdrawn), suspended or changed across the EU.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

Sustained cellular immune dysregulation in individ…

COVID-19, which has killed 1.7 million people worldwide, does not follow a uniform path. Many infected patients remain asymptomatic or have mild symptoms. Others, espe...

New virtual screening strategy identifies existing…

A novel computational drug screening strategy combined with lab experiments suggest that pralatrexate, a chemotherapy medication originally developed to treat lymphoma, c...

Pfizer and BioNTech to supply the U.S. with 100 mi…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a second agreement with the U.S. government to supply an additional 100 million doses of the compan...

European Commission authorizes COVID-19 vaccine Mo…

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the European Commission has granted a cond...

An in vitro study shows Pfizer-BioNTech COVID-19 v…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB...

Serum Institute of India obtains emergency use aut…

AstraZeneca's COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the act...

CureVac and Bayer join forces on COVID-19 vaccine …

Bayer has signed a collaboration and services agreement with CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines b...

New findings help explain how COVID-19 overpowers …

Seeking to understand why COVID-19 is able to suppress the body's immune response, new research from the USC Leonard Davis School of Gerontology suggests that mitochondri...

China grants conditional market approval for Sinop…

The inactivated COVID-19 vaccine developed by Beijing Institute of Biological Products of Sinopharm CNBG has been granted conditional registration by the NMPA of China, C...

Novavax announces initiation of PREVENT-19 pivotal…

Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVEN...

AstraZeneca's COVID-19 vaccine authorised for emer…

AstraZeneca's COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New...

Pfizer and BioNTech to supply the European Union w…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will supply an additional 100 million doses of COMIRNATY®, the companies' COVID-19 Vaccine, to the 2...