Serious liver injury with TEBRAZID (pyrazinamide) or PMS-pyrazinamide and rifampin for the treatment of LATENT tuberculosis - ICN Canada Limited and Pharmascience Inc.

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Contact: Marketed Health Products Directorate (MHPD)

The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD 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
ICN Canada Limited and Pharmascience Inc.
Contact the company for a copy of any references, attachments or enclosures.

Important Safety Information Regarding
Tebrazid^® (Pyrazinamide) and PMS-Pyrazinamide for the Treatment of LATENT Tuberculosis Infection

Updated Safety Information for Patients Taking the Combined Regimen of Tebrazid^® (pyrazinamide) or PMS-Pyrazinamide and Rifampin for latent Tuberculosis (TB) Infection.

Public Advisory: Combined regimen of Pyrazinamide-Rifampin not to be used as first-line treatment for LATENT Tuberculosis (TB) infection due to risk of fatal and severe liver injury. However, pyrazinamide continues to be a first-line drug for the treatment of active TB disease.

Montreal, November 28, 2003 - Following discussions with Health Canada, ICN Canada Limited and Pharmascience Inc., manufacturers of Tebrazid^® (pyrazinamide) and PMS-pyrazinamide, are informing patients and healthcare professionals of emerging safety information in patients taking pyrazinamide.

Pyrazinamide has been approved for use in Canada since 1973 for the treatment of clinical tuberculosis. Recently, cases of fatal and serious liver injury have been reported to the Centers for Disease Control and Prevention (CDC) of the United-States, among patients being treated for latent tuberculosis (also known as preventive therapy or prophylaxis) with the drug combination rifampin and pyrazinamide. As a result, treatment guidelines in the US have been revised. This has prompted Health Canada to issue safety information about the use of this regimen so that ill effects can be reduced. Meanwhile, any adverse effects experienced by those being treated with this regimen should be reported to Health Canada or to the manufacturer. Patients with tuberculosis who have questions about their prescription should contact their physician or pharmacist.

This advisory is in addition to a letter issued to respiratory medicine and infectious disease specialists and to pharmacists. The letter and this advisory are available electronically at: http://www.icncanada.com and medinfo@pharmascience.com

Any suspected adverse incident 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
Toll free for consumers and health professionals:
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 TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.