Risk of venous thromboembolism with combined oral contraceptives such as YASMIN, YASMINELLE, YAZ and others: clarification

The findings of two new epidemiological studies confirm the results of the revaluation (completed in May 2011) of the YASMIN, YASMINELLE and YAZ contraceptives by the Pharmacovigilance Working Party of the European Medicines Agency: the risk of venous thromboembolism of these drospirenone-containing contraceptives is higher than that of second-generation contraceptives (containing levonorgestrel) but is similar to that of third generation contraceptives (containing desogestrel or gestodene). This risk is nevertheless very low. The benefit / risk balance of these medicinal products remains positive.

The Pharmacovigilance Working Party (PhVWP = Pharmacovigilance Working Party) of the European Medicines Agency (EMA = European Medicines Agency) has re-evaluated two new epidemiological studies about the risk of venous thromboembolism (VTE) associated with combined oral contraceptives (COCs) containing drospirenone, such as YASMIN, YASMINELLE and YAZ.

The results of the new studies do not alter the conclusions reached by the PhVWP in May 2011, under which:
- the risk of VTE observed with any COC (including those containing drospirenone) is very low;
- the risk observed with COCs containing drospirenone is higher than that observed with COCs containing levonorgestrel (also called second generation COCs);
- the risk observed with COCs containing drospirenone is similar to that seen with COCs containing desogestrel or gestodene (also called third- generation COCs).

Currently available information on COCs containing drospirenone authorized in the European Union confirms the latest available data.

The benefit / risk balance of the YASMIN, YASMINELLE, YAZ contraceptives and others remains positive when used according to the recommendations outlined in the leaflet of these medicines particularly with regard to the contra-indications.

The holder of the marketing authorisation of these medicinal products  is already asked to include in the summary of product characteristics and patient leaflet a text explaining the risk comparison. A new update of these documents is not being considered.
More information is available in the monthly report of the PhWP.

Contact: vig@afmps
 

 

 

Last updated on 08/03/2012