Please note: This article is from Dec. 2005, so the information is a little old.

I will add this article to the Depo Provera sticky (coming soon).

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Taken from: http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/2005/depo-provera_pa_ap_e.html


KIRKLAND, QUEBEC - June 30, 2005 - Pfizer Canada Inc. in consultation with Health Canada, would like to inform you of important updated safety information for DEPO-PROVERA (medroxyprogesterone acetate injectable suspension, USP), indicated for conception control (prevention of pregnancy), treatment of endometriosis (tissue of the uterus abnormally growing outside of the uterus), treatment of recurrent and/or metastatic endometrial cancer (cancer of the lining of the uterus) or renal cell cancer (kidney cancer) and treatment of recurrent inoperable or metastatic breast cancer in post-menopausal women.

As a result of new clinical studies, one with premenopausal adult women (age 25-35 years) and one with adolescent women (age 12-18 years) using DEPO-PROVERA for conception control, data regarding the use of DEPO-PROVERA and its associated effect on bone mineral density are now available. The data indicate that women who use DEPO-PROVERA may lose significant bone mineral density. The longer DEPO-PROVERA is used, the more bone mineral density may be lost. Bone mineral density may not return completely once use of DEPO-PROVERA has been discontinued. This is of particular concern when DEPO-PROVERA is used in adolescence (teenager years) when bone mineral density should instead be increasing. Loss of bone mineral density can cause osteoporosis (decrease in bone mass and density) and increase the risk that bones might break, especially after menopause (the end of menstrual periods).

There have been cases of osteoporosis and fracture (broken bones) associated with the use of DEPO-PROVERA.

Patients should be aware that DEPO-PROVERA should be used as a birth control method or endometrial treatment only if other treatments have been considered to be unsuitable or unacceptable and should be used for the shortest period of time possible. The risks and benefits of treatment should be carefully re-evaluated on a regular basis in all users of this drug.

DEPO-PROVERA should not be used before menarche (the onset of menstrual periods).

Patients should inform their doctor if they use any other medications (including steroids or anti-seizure medications), have a history of bone disease or anorexia nervosa (an eating disorder), have a strong family history of osteoporosis, drink alcohol or smoke. These conditions represent additional risk factors for low bone mineral density.

Patients should talk to their doctor about how to reduce the risk of low bone mineral density, and about calcium and vitamin D intake. Patients should be aware that monitoring of bone mineral density with a bone test may be recommended for some users of DEPO-PROVERA.

This public advisory is in addition to a letter issued to health care professionals reminding them of the above-mentioned safety information. As well, the product monograph for DEPO-PROVERA has been revised to inform doctors and other healthcare professionals regarding additional guidance on the appropriate use of DEPO-PROVERA.

For more information about the revisions to the prescribing information, patients should consult their healthcare professional. Patients should NOT discontinue their medication without consulting their doctor first.

For media inquiries, please contact Sophie McCann, Pfizer Canada Inc, (514) 693-4161.

The safety of patients is a priority for Pfizer Canada Inc. Information about adverse drug reactions is gathered by both Pfizer Canada Inc. and Health Canada, via its Canadian Adverse Drug Reaction Monitoring Program (CADRMP). Any suspected adverse drug reactions in patients receiving Depo-Provera can be reported to:

Pfizer Canada Inc.
Safety and Medical Information
P.O. Box 800
Pointe-Claire, Quebec
H9R-4V2
1-800-463-6001

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

For other inquiries, please refer to contact information:

Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
E-mail: bmors_enquiries@hc-sc.gc.ca
Telephone: (613) 941-3171
Fax: (613) 941-1365