Canada. Health Canada is advising consumers that the authority has reached an agreement with Berlex, manufacturer of ethinylestradiol/cyproterone (Diane-35) on revised labelling for its use in Canada. The following warnings are included on the new package insert:

• Ethinylestradiol/cyproterone (Diane-35) must not be used in women who currently have, or have a history of, thromboembolic disorders or thrombophlebitis.

• Ethinylestradiol/cyproterone (Diane-35) should not be prescribed for contraception alone.

• Women should not use oral contraceptives during ethinylestradiol/cyproterone (Diane-35)-treatment.

• Ethinylestradiol/cyproterone (Diane-35) should be stopped 3 4 months after the complete resolution of the signs of acne.

• In some published studies, women who used ethinylestradiol/cyproterone (Diane-35) appeared to have a higher risk of blood clots than women who used combination oral contraceptives.

• Cigarette smoking increases the risk of serious cardiovascular adverse effects from ethinylestradiol/cyproterone (Diane-35), and the risk increases with heavy smoking and age (more marked in women aged ≥ 35 years).

Patients are advised to inform their doctor if they currently have, or have a history of, blood clots, myocardial infarction, stroke or chest pain.

References:

Advisories and Warnings. Health Canada, 12 May 2005 (http://www.hc-sc.gc.ca).