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Withdrawal of Market Authorization for Prexige (lumiracoxib) - For Health Professionals
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The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Novartis Pharmaceuticals Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
October 3, 2007
Subject: Withdrawal of Market Authorization for Prexige* (lumiracoxib) tablets
Dear Health Care Professional,
At Health Canada's request, Novartis Pharmaceuticals Canada Inc. (Novartis) is ceasing sales and marketing of Prexige* (lumiracoxib) tablets immediately.
Prexige* is a selective COX-2 inhibitor in the class of drugs called NSAIDs (non-steroidal anti-inflammatory drugs) indicated for the symptomatic treatment of osteoarthritis at a dose of 100 mg once daily.
Following Health Canada's review of all safety and efficacy data requested from Novartis, Health Canada's assessment has concluded that the risk of serious hepatotoxicity associated with the use of Prexige cannot be safely and effectively managed. Health Canada has thus requested that Novartis stop sales of Prexige in Canada.
Consistent with this decision to cease sales and marketing of Prexige*, Novartis is asking Canadian pharmacists and distributors to return the product to the company. Patients taking Prexige* should discontinue treatment and contact their physician for advice about alternative therapies.
Advice to Health Care Professionals:
Prescribers are advised:
- Not to initiate treatment of new patients;
- To advise patients to discontinue Prexige*;
- To review treatment options for patients currently taking Prexige*;
- To return Prexige* samples to CLS Med-Turn International.
Pharmacists are advised:
- Not to dispense further prescriptions for Prexige*;
- To advise patients to discontinue Prexige* and contact their physicians if they have any concerns;
- To return Prexige* tablets to CLS Med-Turn International.
Consumers should return the product to their pharmacy. In order to avoid contaminating ground or municipal water systems, the product should not be flushed down the toilet or sink.
Novartis Pharmaceuticals Canada Inc. reiterates its commitment to the delivery of quality pharmaceutical products and is committed to ensuring the timely dissemination of new information that is important to physicians and patients. A public communication will be made available on Health Canada's website and on 
Novartis' website.
Managing marketed health product-related adverse reactions is dependent upon health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious hepatic events or other serious or unexpected adverse reactions in patients receiving Prexige* should be reported to Novartis or Health Canada at the following addresses:
385 Bouchard Blvd.
Dorval, QC H9S 1A9
e-mail address: drug.safety@novartis.com
Prexige Hotline: 1-877-519-5399
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866-234-2345
Fax: 866-678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel.: 613-954-6522
Fax: 613-952-7738
Should you have any questions or require additional information regarding the use of Prexige*, please contact the Prexige* Hotline at 1-877-519-5399.
Sincerely,
original signed by
Jean-Marie Leclerc, M.D. FRCP(C)
Chief Scientific Officer and
Senior Vice-President Clinical and Regulatory Affairs
