Advisory
2005-39
May 12, 2005
For immediate release
Health Canada advises consumers of new warning For DIANE-35
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.
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Media Inquiries:
Media Relations
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
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