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Health Canada
Health Products and Food Branch
Direction générale des produits de santé et des aliments
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The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and Biologics and Genetic
Therapies Directorate (BGTD) posts 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 i s duplicated text of a letter from Sigma-Tau Pharmaceuticals, Inc
Contact the company for a copy of any references, attachments or enclosures.
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Sigma Tau Pharmaceuticals Inc.
2000 Ellesmere Road, Unit 16
Scarborough, Ontario
M1H 2W4
telephone: 416-438-6727
IMPORTANT NEW SAFETY INFORMATION REGARDING MATULANE®
(PROCARBAZINE HYDROCHLORIDE) CAPSULES FORMERLY MARKETED UNDER THE NATULAN® NAME
July 18, 2002
Dear Health Care Professionals,
The purpose of this advisory is to bring to your attention additional information, from literature reports, regarding the development of lung cancer as a secondary nonlymphoid malignancy in Hodgkin’s patients receiving the MOPP regimen (mechlorethamine, vincristine, procarbazine and prednisone) as therapy. Matulane (procarbazine hydrochloride) is one component of the MOPP regimen.
This advisory is based on several literature reports of lung cancer as one of the most common second nonlymphoid malignancies as well as a recent publication in the Journal of the National Cancer Institute (Volume 94, No. 3, February 6, 2002) describing a case-control study of the occurrence of lung cancer in Hodgkin’s disease patients with the MOPP regimen and radiation taking into account tobacco use.
Results suggest an increased risk of lung cancer in a dose-dependent fashion which is multiplied with tobacco use. Patients are advised to cease smoking before starting MOPP therapy.
Please consider this information when using Matulane (procarbazine hydrochloride) in your practice and, if appropriate, provide to others involved with patient care in your professional environment.
The updated full prescribing information for Matulane® for healthcare professionals and information for consumers will be posted at www.sigmatau.com shortly.
Further information may also be obtained by calling Sigma-Tau Pharmaceuticals, Inc., at 416-438-6727 extension 249.
The identification, characterization, and management of drug-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Any occurrences of adverse cardiaclate adverse events, secondary malignancies events or other serious and/or unexpected adverse events in patients who received MATULANE (procarbazine hydrochloride) should be reported to the Sigma Sigma-Tau Pharmaceuticals at the following address:
Sigma-Tau Pharmaceuticals, Inc.
2000 Ellesmere Road, Unit 16
Scarborough Ontario
M1H 2W4
Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.
original signed by
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Les Szendrovits
Director - Scientific Affairs
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Any suspected adverse drug reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
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 ADR Reporting Form can be found in The Canadian Compendium of Pharmaceuticals and Specialties, or on the
TPD web site, along with the ADR Guidelines at:
http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/forms/adverse_e.pdf
http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/guides/adr/adr_guideline_e.pdf |
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