Archive – Health Canada Advises Consumers of New Warning for DIANE-35
- Starting date:
- May 12, 2005
- Posting date:
- May 12, 2005
- Type of communication:
- Source of recall:
- Health Canada
- Important Safety Information, Labelling and Packaging
- Healthcare Professionals, General Public
- Identification number:
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
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
To report an Adverse Reaction, consumers and health professionals may call toll free:
For other inquiries, please refer to contact information.
- 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