The European Medicines Agency has started a review of combined hormonal contraceptives containing chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestodene, nomegestrol, norelgestromin or norgestimate
08.02.2013
The European Medicines Agency (EMA) has started a review of several combined hormonal contraceptives that are authorised in the EU. Combined hormonal contraceptives contain two types of hormones, estrogen and progesterone (gestagen). This review includes all contraceptives containing the following gestagenes: chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, nomegestrol, norelgestromin and norgestimate.
The review of these contraceptives has been requested by the French Agency for the Safety of Health Products (ANSM), after a concern arose in France about the risk of venous thromboembolism (VTE), the forming of blood clots in veins. It is well known that the risk of venous thromboembolism associated with the use of combined oral contraceptives depends on the estrogen level and type of gestagen they contain. Even though the total risk associated with the use of these medicines is low, it is known that the risk associated with certain gestagens is higher than the risk associated with the levonorgestrel gestagen.
The EMA will review all available data on the risk of venous thromboembolism associated with the use of these contraceptives and give an opinion whether modifications in prescription advising are necessary in the EU. The review will also encompass the risk of arterial thromboembolism (the forming of blood clots in arteries that potentially may cause a stroke or a coronary attack). This risk is very low and currently is not associated with any particular gestagen.
In the previous reviews of combined oral contraceptives, the EMA concluded that their absolute risk of venous thromboembolism is low and that detailed information about that risk and its treatment is included in the Summaries of Product Characteristics1,2.
More about these medicines
Combined hormonal contraceptives encompassed by this review are sometimes called "third or fourth generation” contraceptives that are available in the form of tablets, transdermal patches and pessaries.
Except for the medicinal products Zoely (nomegestrol acetate/estradiol), Ioa (nomegestrol acetate/estradiol) and Evra (norelgestromin/ethinilestradiol), that are authorised centrally, all other combined contraceptives are authorised by national procedures in the EU.
More about the procedure
The review of combined hormonal contraceptives has been initiated at the request of France, under Article 31 of Directive 2001/83/EC.
The review is carried out by the Pharmacovigilance and Risk assessment Committee (PRAC), that is responsible for review of safety issues related to human medicinal products. The PRAC will give its recommendations that will be forwarded to the Committee for Human Medicinal Products (CHMP), that will adopt the EMA’s opinion. The final phase of this procedure is the adoption of legally binding decisions by the European Commission, that applies to all EU Member States.
