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Published: March 2002

Letter to Doctors/Midwives/Pharmacists about VTE with cyproterone-containing OCs

Information on this subject has been updated. Read the most recent information.

March 2002

Dear Doctor/Midwife/Pharmacist

Studies show that the risk of venous thromboembolism (VTE) with Diane 35/35 ED™ and Estelle 35/35 ED™ is at least as great as that with third generation oral contraceptives (OCs).  Diane 35 and Estelle 35 are brand names of medicines containing cyproterone acetate with ethinyloestradiol.  The risk of VTE with third generation OCs is twice that of second generation OCs.

This advice from the Medicines Adverse Reactions Committee (MARC) is based on a recent study in the Lancet1 and previously published smaller studies.2,3  Enclosed is a Prescriber Update article, which explains the findings of these studies in more detail.

The Centre for Adverse Reactions Monitoring in Dunedin has received 18 reports of VTE, including 15 of pulmonary embolism, in women taking cyproterone acetate with ethinyloestradiol.

The MARC reminds practitioners that Diane 35 and Estelle 35 are indicated only in women for the treatment of androgen-dependent diseases (including pronounced acne) and polycystic ovary syndrome, and for oral contraception in these women.  All patients currently on these medicines should be reviewed at their next visit (or repeat prescription) for the appropriateness of this therapy.  Practitioners must consider the risks of VTE when initiating and continuing treatment with Diane 35 and Estelle 35 in all situations.  Both new and current patients should be fully advised of the risks of VTE, and be informed of the symptoms of VTE and situations of increased risk.

When prescribing combined oral contraceptive therapy to women, practitioners should follow the Ministry of Health advice from the last six years (enclosed; updated to include cyproterone-containing OCs) on the use of combined OCs.  Consider prescribing a low dose second generation OC where the woman has no contraindications and has indicated that she wishes to take a combined OC.  Women with mild acne should not commence on a cyproterone-containing OC as first-line contraception.  It is important that practitioners remain vigilant about the risk of VTE with combined OCs, and the higher risk of VTE with the third generation OCs and cyproterone-containing OCs compared with second generation OCs.

Medsafe has also updated the June 2000 patient leaflet on OCs and blood clots to include information on the risk of VTE with Diane 35 and Estelle 35.  A copy is enclosed.  Bulk copies have been sent to general practitioners, pharmacies, hospitals, and family planning clinics.  Please make these leaflets available to women.

Additional copies of the patient leaflet are available - phone (04) 496 2277, fax (03) 479 0979, email pubs@moh.govt.nz or post an order to the Ministry of Health, c/- Wickliffe Ltd, PO Box 932, Dunedin.  The leaflet and all articles, including prescribing advice, published by Medsafe on OCs are available at www.medsafe.govt.nz/hot/contraceptives.htm

Product information in the form of consumer medicine information (CMI) is also available for consumers.  This can be downloaded from the Medsafe web site (www.medsafe.govt.nz/Consumers/cmi/d/diane35.htm or www.medsafe.govt.nz/Consumers/cmi/d/diane35ED.htm).

Yours sincerely

Dr Stewart Jessamine
Principal Technical Specialist

References
  1. Vasilakis-Scaramozza C, Jick H. Risk of venous thromboembolism with cyproterone or levonorgestrel contraceptives. Lancet 2001; 358:1427-1429.
  2. WHO Collaborative Study of Steroid Hormone Contraception and Cardiovascular Disease. Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. Lancet 1995; 346: 1582-88.
  3. Parkin L, Skegg DCG, Wilson M, Herbison GP, Paul C. Oral contraceptives and fatal pulmonary embolism. Lancet 2000; 355: 2133-2134.

 

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