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 Pfizer Canada Inc.
Contact the company for a copy of any references, attachments or enclosures. |
Health Canada Endorsed Important Safety Information on
DEPO-PROVERA* (medroxyprogesterone acetate) |
![Pfizer](/web/20061212010619im_/http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/images/pfizer.gif)
November 18, 2004
Subject: Important Safety Update: Potential Effect of DEPO-PROVERA*
(medroxyprogesterone acetate) on Bone Mineral Density (BMD)
changes in adults and adolescents
Dear Health Care Professional,
Pfizer Canada Inc. would like to inform you of important updated safety information,
currently under evaluation by Health Canada for DEPO-PROVERA
(medroxyprogesterone acetate suspension for injection) indicated for the prevention of
pregnancy in women of child-bearing potential and treatment of endometriosis. As a
result of new clinical studies, one with adults and one with adolescents, we now have
clinical data regarding the use of Depo-Provera and its associated effect on bone
mineral density (BMD). The data suggest that women who use DEPO-PROVERA
Contraceptive Injection may lose significant BMD. Bone loss is greater with increasing
duration and may not be completely reversible. It is unknown if use of DEPO-PROVERA
during adolescence or early adulthood, a critical period of bone accretion, will reduce
peak bone mass and increase the risk of osteoporotic fracture in later life.
Pfizer is currently working in collaboration with Health Canada to revise the Product
Monograph. The proposed update to the DEPO-PROVERA labeling will affect the
following section:
- INDICATIONS and CLINICAL USE: Addition of a Risk-Benefit statement stating
that loss of BMD in women of all ages, and the impact on peak bone mass in
adolescents, should be considered, along with the decrease in BMD that occurs
during pregnancy and/or lactation, for women who use Depo-Provera long term
- WARNINGS: Addition of statements regarding loss of bone mineral density in
adults and adolescents females
- DOSAGE AND ADMINISTRATION: Addition of a cautionary statement about the
use of DEPO-PROVERA Contraceptive Injection in adolescence and early
adulthood
- ADVERSE REACTIONS: Addition of a statement based on post-marketing
experience regarding rare cases of osteoporosis including osteoporotic fractures
reported
Patient information labeling is also being updated to reflect the BMD results from the
above studies. The proposed revised text is also under evaluation by Health Canada.
We are committed to working with Health Canada towards ensuring that DEPOPROVERA
is used safely and effectively and to working in collaboration with you for the
safety and well being of all patients receiving Depo-Provera. Should you have any
questions, please contact Pfizer Canada's Medical Information
at 1 800 463-6001. Further communications will be issued as soon as the product Monograph discussions are finalized with Health Canada.
Sincerely,
original signed by
Bernard Prigent, M.D.
Vice President & Medical Director
Pfizer Canada Inc.
The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of serious and/or unexpected adverse reactions in patients receiving DEPO-PROVERA* (medroxyprogesterone acetate) should be reported to Pfizer Canada Inc. or Health Canada at the following addresses:
Pfizer Canada Inc.
P.O. Box 800 / C.P. 800
Pointe Claire / Dorval (Québec)
Tél: (514) 695-0500
Fax/Téléc: (514) 693-4118
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. |
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