There is growing concern amongst users of oral contraceptives and HRT treatments which contain synthetic progestins following reports on possible links between synthetic progestins and breast cancer, as well as other health risks. Synthetic progestins are known to lead to oestrogen dominance which is, in turn, linked with breast cancer.

Can the Commission indicate what research is being undertaken to establish whether women are at risk from synthetic progestins; what guidance is being given to medical practitioners about using products containing synthetic progestins while the safety of these products is in doubt; and what public information is being provided to EU citizens to enable them to make informed choices about pharmaceutical products containing synthetic progestins?

P-1979/03EN
Answer given by Mr Liikanen on behalf of the Commission
(2 July 2003)

The Commission is aware of the concern amongst users of combined oral contraceptives (COCs) and Hormone Replacement Therapy (HRT).

The European Agency for the Evaluation of Medicinal Products (EMEA) Committee for Proprietary Medicinal Products (CPMP) on 28 September 2001 adopted a Public Assessment Report on "Combined oral contraceptives and venous thromboembolism" and a Position statement after its assessment of "third generation combined contraceptives containing the progestins desogestrel or gestodene and the risk of venous thromboembolism."

In this report the CPMP considers that the Summaries of Products Characteristics (SPC) (i.e. the scientific documentation related to the products) and the User Package Leaflets should reflect the precautions for use of these products and should be communicated to the prescribers of COCs as well as the women in need of contraceptive therapy.

Last December 2002 the Member States medicine authorities adopted a core SPC for HRT with information on the risk of cardiovascular disease and cancer.

On the other hand in order to assess the raised pharmacovigilance signals on venous thromboembolism, COCs and HRT are involved in a specific study and review at the Pharmacovigilance working group of the CPMP. There is not yet a definitive scientific position as the evaluation is going on.