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View Full Version : Prexige (Lumiracoxib) Licence Has Been Suspended, UK



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12-25-2007, 11:13 PM
The Medicines and Healthcare products Regulatory Agency (MHRA) is informing healthcare professionals about the suspension of the licence for Prexige (lumiracoxib) due to the safety concerns about possible liver damage for patients.

In August 2007, following analysis of data available at that time, the MHRA introduced new prescribing restrictions (contraindications) for patients with current or previous liver problems, and additional requirements for blood tests before and during lumiracoxib treatment for all other patients.

The Commission on Human Medicines (CHM) has now reviewed the latest worldwide data on the safety of lumiracoxib, in particular relating to liver adverse reactions. Importantly, the latest data shows an increase in the number of cases of serious liver reactions that have occurred with the licensed 100mg dose, and in some cases the reactions have been associated with short term use (less than one month).

Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA said, "The MHRA carefully reviewed the latest evidence, and sought independent expert advice from the Commission on Human Medicines (CHM). In light of the latest data on liver toxicity associated with lumiracoxib, CHM advised that previous measures could not be relied upon to guarantee patient safety. Patients taking Prexige should make an appointment to see their doctor at the next convenient opportunity. "

Notes:

- Prexige is used to treat painful symptoms of osteoarthritis of the knee and hip and was first made available in the UK in December 2005. Approximately 8.5 million prescriptions of lumiracoxib have been written worldwide since launch in July 2005. In the UK approximately 5,000 patients have received one or more prescriptions for lumiracoxib in the year October 2006 - September 2007.

- Lumiracoxib has been approved in more than 50 countries worldwide. Since its first launch in Brazil on 01 July 2005, lumiracoxib has been marketed in 30 countries worldwide, including 9 countries in the EU. On 10 Aug 2007 Australia withdrew the marketing authorisation due to hepatic safety concerns based on reports of liver failure, and soon after that, New Zealand withdrew the marketing authorisation for 200 mg and 400 mg tablets (but kept the licences of 100 mg once daily for osteoarthritis with additional restrictions on use). Turkey suspended the marketing authorisation for 100mg pending further review. In September, the Food and Drug Administration in the United States issued a 'non-approvable' letter for lumiracoxib 100mg, and in October, Canada withdrew the marketing authorisation for 100mg and Aruba withdrew the product licenses for 100mg, 200mg and 400mg.

- Up to 13 November 2007, we have received 23 reports of suspected adverse reactions to lumiracoxib in the UK since March 2006 through the Yellow Card Scheme. Three of these were liver reactions (detected by blood tests). None of these reactions were said to have been severe* but 2 were considered serious by the reporter with the remaining case involving patient hospitalisation. We have not received any reports of fatal adverse reactions to lumiracoxib in the UK. It is important to note that not all adverse drug reactions are reported and therefore these data cannot be used to calculate the frequency of adverse reactions. In addition, a report of a suspected adverse reaction does not necessarily mean that it was caused by the drug. Factors such as other medicines taken at the same time or the patient's underlying condition need to be taken into account when considering whether the drug caused the reaction.

[*The definition of severe is hepatic failure or "Hy's case" (transaminases > 3ULN and bilirubin >2ULN) or a fatal outcome or liver transplantation.]

- Patients who are feeling well and who are gaining benefit from Prexige may continue taking their treatment, but should arrange an appointment with their doctor at the next convenient opportunity, to discuss alternative treatment.

- Patients who are taking Prexige and who feel unwell (e.g. if they have nausea, vomiting, loss of appetite, tiredness, stomach pains, dark urine, or itching or yellowing of the skin [jaundice]) should stop taking Prexige immediately and arrange to see their doctor as soon as possible.

- The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone - the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

http://www.mhra.gov.uk (http://www.mhra.gov.uk/)