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Diane-35, Yasmin & Hormonal Control of Acne

Alert - Diane-35 drug is not available in the U.S.

Are there really problems with Diane-35?

  • Society of Obstetrics and Gynecologists of Canada replies - January 17, 2003 Ottawa - The SOGC is very concerned that a recent news story on CBC's 'Disclosure' may have had the unfortunate effect of scaring many users of Diane 35 into stopping medication without consulting their doctors. "Regrettably, the 'Disclosure' feature chose to sensationalize an incomplete scientific report submitted as a letter to the Lancet in October 2001, which claimed that Diane 35 caused more blood clots than other oral contraceptives." said Dr. Robert Reid, Chairperson of the SOGC's National Contraceptive Awareness Program (CAP). "That study failed to take into account other characteristics of women who take Diane35 that could explain most, if not all, of the reported differences."
  • CBC Disclosure show - January 14, 2003
    Disclosure has learned that every day thousands of young Canadian women are taking a potentially dangerous pill and many don't realize it. The pill is called Diane-35. More than 800,000 prescriptions were written for the drug last year and the majority of Canadian women are taking it for birth control. That's the problem. The drug was approved by Health Canada as a treatment for severe acne.

  • Health Canada links to warnings posted in UK - December 2002
    Diane-35 (Dianette in the UK), should only be used to treat severe acne and hirsutism. It is indicated for women with severe acne which has not responded to oral antibiotics, or for moderately severe hirsutism. It contains cyproterone acetate (2mg), an anti-androgenic progestogen, and ethinylestradiol (35µg) and it is administered for 21 days of each menstrual cycle. It therefore has a similar composition to that of a combined oral contraceptive (COC) and provides effective contraception.

  • Venous thromboembolism warning from Australia -
  • It has been estimated that for every 10,000 women on a pills like Diane-35 for a year, it is estimated that about 3 to 4 women per 10,000 per year may develop thrombosis. In Australia, products containing low dose cyproterone (2 mg) combined with ethinyloestradiol (see Table 2) are not indicated for contraception but for treatment of signs of androgenisation in women. These include severe acne where prolonged oral antibiotics or local treatment alone has not been successful, and idiopathic hirsutism of mild to moderate degree. These products will also provide effective oral contraception in this patient group.

    I never precribe Diane-35 unless patients have acne. It would be wise to discontinue Diane-35 if you feel that the risks outway the benefits. The drug is not sold in the United States, but it is used around the world. In Europe it is known as Dianette, in Asia and Pacific it's Diane-35.

  • Company Press Release
       - 1998 - Berlex Canada

  • Focus on Diane-35
       - DermWeb - Dr. Stuart Maddin - Vancouver

  • Oral Contraceptives for Treatment of Acne
       - 1997 Medical Sciences Bulletin

  • Questions and Answers

  • Prescribing Information
       - Schering - New Zealand DermNet

  • Consumer Medicine information
       - MedSafe New Zealand

  • Diane-35 and anti-androgenic treatment
       - DermNet New Zealand

  • Diane - Cyproterone Discussion Forum