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 Adverse Cases


Back Reported Adverse Drug Reaction Cases
Venous thromboembolism with third generation oral contraceptives and cyproterone
Third generation oral contraceptives

Venous thromboembolism (VTE) is a recognised complication of oral contraceptives. For a number of years it has been debated whether "third generation" (containing desogestrel or gestodene) combined oral contraceptive pills (OCP) carry a higher risk of VTE than "second generation" OCP (containing levonorgestrel or norethist-erone). A number of independent studies addressing the issue have been published.1,2 The European Agency for the Evaluation of Medicinal Products (EMEA) released its final position statement in September 2001 which indicates a "small increased risk of venous thrombo-embolism" with OCPs containing desogestrel or gestodene compared with second generation OCPs.3 The overall conclusions of both the EMEA and an earlier statement from New Zealand Medsafe in 1996 4 are as follows:

  • VTE is a rare adverse effect of all combined oral contraceptives. The level of risk is low (and lower than in pregnancy) and the benefits of the use of OCPs compare favourably with the risks. The risks of VTE are highest in the first year of use.
  • The risk of developing VTE with third generation OCPs is about twice that of second generation OCPs.
  • It has been estimated that for every 10,000 women on a second generation OCP for a year, 2 women would be expected to develop a clot. For third generation OCPs, that figure is estimated to be about 3 to 4 women per 10,000 per year.
  • Major risk factors for VTE include inherited thrombophilia, obesity, smoking, old age, trauma, pregnancy, surgery, and immobilisation. (see article in the Australian Prescriber accompanying this Bulletin).5

Third generation OCPs marketed in Australia are shown in Table 2. These products are not extensively used in Australia.

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Combined cyproterone products

New Zealand Medsafe has also released a statement concerning oral contraceptives containing cyproterone.6 The conclusion of its review is that:

  • The risk of developing VTE with cyproterone OCPs is about 4 times that of second generation OCPs.
  • It has been estimated that for every 10,000 women on an OCP containing cyproterone, about 8 women per year would be expected to develop a clot.

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 but they are not available on the PBS.

ADRAC suggests that all women being prescribed combined oral contraceptives or combined cyproterone products should be advised of the benefits and risks. Each woman should be assessed carefully for inherent or pre-existing risk factors, including family history. For cyproterone, the indications for use should be followed.

Table 2

Combined Oral Contraceptive and Cyproterone Products Available in Australia

Second Generation OCPs

Levonorgestrel

Norethisterone

Biphasil, Levlen, Loette, Logynon, Microgynon, Monofeme, Nordette, Nordiol, Sequilar, Trifeme, Triphasil, Triquilar

Brevinor, Improvil, Norimin, Norinyl, Synphasic

Third Generation OCPs

Desogestrel

Gestodene

Marvelon

Femoden, Minulet, Tri-Minulet, Trioden

Cyproterone

Brenda, Diane, Juliet

duloxetin urologie ogsportforskning.site duloxetin hexal 30 mg
References:
  1. Committee on Safety of Medicines/Medicines Control Agency. Combined oral contraceptives containing deso-gestrel or gestodene and the risk of venous thrombo-embolism. Curr Problems Pharmacovigilance 1999; 25: 12.
  2. Spitzer W, Lewis MA, Heinemann LAJ, Thorogood M, MacRae KD. Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. BMJ 1996; 312: 83-88.
  3. The European Agency for the Evaluation of Medicinal products, Committee for Proprietary Medicinal Products (CPMP). Position Statement: CPMP concludes its assess-ment of ‘third generation’ combined oral contraceptives and the risk of venous thromboembolism. Available from: http://www.emea.eu.int/pdfs/human/regaffair/0225001en.pdf (viewed 30 January 2002) PDF icon(104kb).
  4. Medsafe Editorial Team. The risk of venous thrombo-embolism with third generation oral contraceptives. Available from http://www.medsafe.govt.nz/Profs/PUarticles/contraceptivesJuly96.htm (viewed 4 March 2002).
  5. Weisberg E. Contraception, hormone replacement therapy and thrombosis. Aust Prescr 2002; 25: 57-59.
  6. Savage R. Venous thromboembolism with Diane 35 and Estelle 35. Available from http://www.medsafe.govt.nz/Profs/PUarticles/VTEwithCPA.htm (viewed 9 April 2002).

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