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Health Canada Advises Consumers of New Warning For DIANE-35

May 12, 2005 | Health Canada

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.

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