Health Canada advises consumers of new warning For DIANE-35

Advisory
2005-39
May 12, 2005
For immediate release

OTTAWA - Health Canada is advising consumers of important information about the use of the prescription drug DIANE-35. Berlex and Health Canada reached an agreement on a new version of the Product Monograph. DIANE-35 is used for the treatment of women suffering from pronounced forms of acne. The drug should not be promoted nor used as a method of birth control.

The new patient package insert includes the following information:

• DIANE-35, as with all estrogen/progestogen combinations must not be used in women with thrombophlebitis, thromboembolic disorders (blood clots), or a history of these conditions.
• DIANE-35 users appear to have an elevated risk of blood clots compared to users of combination oral contraceptives in some published studies.
• DIANE-35 should not be prescribed for the purpose of birth control alone.
• Oral contraceptives should not be taken during treatment with DIANE-35.
• DIANE-35 should be discontinued 3 to 4 months after signs of acne have completely resolved.
• Consumers should be aware that cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from DIANE-35 use. This risk increases with age and heavy smoking (15 or more cigarettes a day) and is more marked in women over 35-years of age. Women who use estrogen/progestogen combinations should not smoke.

Patients should inform their doctor if they have or have had blood clots in the legs, lungs, eyes or elsewhere, or a stroke, heart attack, or chest pain.

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 thromboembolic disorders (blood clots) or other serious and/or unexpected adverse reactions in patients receiving DIANE-35® should be reported to Health Canada at the following address:

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.

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.

• Report of Suspected Adverse Reaction due to Health Products Marketed in Canada (Vaccines excluded)
• Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Guidelines for the Voluntary Reporting of Suspected Adverse Reactions to Health Products by Health Professionals and Consumers

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Media Relations
Health Canada
(613) 957-2983

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