Healthy Skepticism AdWatch
AdWatch illuminates the logical, psychological and pharmacological techniques used in drug advertisements.
April 2006, Australia
Estelle-35ED (cyproterone-oestradiol) from Douglas
Estelle-35ED (cyproterone-oestradiol) (Douglas)
She needs safe and reliable contraception, not a treatment for severe acne!
Oral contraceptives containing cyproterone have been associated with about a four-fold higher incidence of venous thromboembolism (VTE) than other combined oral contraceptives.[1],[2] The approved indication for these products is treatment of signs of androgenisation, such as severe acne and hirsutism (see below) and they should generally be used for a maximum of about 6 months. The manufacturer’s Consumer Medicine Information leaflet for EstelleTM-35ED states that it ‘should be withdrawn 3-4 cycles after the treated condition has completely resolved.’
The UK Committee on Safety of Medicines (CSM) has advised that DianetteTM (which contains the same ingredients as EstelleTM-35ED) ‘is not indicated for use solely as an oral contraceptive; it is a treatment for women with severe acne that has not responded to oral antibiotics, or for moderately severe hirsutism’.[3]
In Canada, de facto direct-to-consumer advertising was used to promote a similar product, Diane-35TM. Many women without acne (let alone severe acne) were prescribed it. After a critical television documentary was broadcast, the rate of treatment initiation with Diane-35 TM declined, and the number of women switching to an approved oral contraceptive increased.[4]
The Australian Adverse Drug Reactions Advisory Committee (ADRAC) has recommended that the indications for use of cyproterone containing pills should be followed.[5] The Australian Medicines Handbook lists ‘contraception in absence of androgenic symptoms’ as a contraindication for cyproterone.[6]
The approved indication for EstelleTM-35ED is:
Treatment of signs of androgenisation in women such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. EstelleTM-35ED will also provide effective oral contraception in this patient group.
If the hirsutism has only recently appeared or has lately intensified to a considerable extent the cause (androgen producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.
References
1. CSM. Cyproterone acetate (Dianette): risk of venous thromboembolism (VTE). Curr Probl Pharmacovigilance 2002; 28: 9-10.
2. Australian Medicines Handbook, Chapter 17, Section 17.1.1 Combined oral contraceptives, p. 639; 2006.
3. Douglas Pharmaceuticals Australia Ltd. Estelleâ„¢- 35 ED Approved Product Information, 2004.
4. Mintzes B, Morgan S, Bassett KL Medicine by media: did a critical television documentary affect the prescribing of cyproterone—estradiol (Diane-35)? CMAJ. 2005 Nov 22;173(11):1313-5.
5. ADRAC. Venous thromboembolism with third generation oral contraceptives and cyproterone. Aust Adv Drug Reactions Bull 2002; 21: 7-8.
6. Australian Medicines Handbook, Chapter 17, Section 17.1.1 Combined oral contraceptives, p. 641, 2006.
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