European Medicines Agency update on combined contraceptives

European Medicines Agency (EMA)The European Medicines Agency is issuing this update in response to growing media reports about combined contraceptives and venous thromboembolism (blood clots in veins). It is well-established that combined contraceptives carry a very rare risk of blood clots, and that the risk differs between types of combined contraceptives. These products are constantly and rigorously kept under close monitoring. There is currently no new evidence that would suggest any change to the known safety profile of any combined contraceptives marketed today. Therefore, there is no reason for any woman to stop using her contraception.

The European regulatory network has a robust system in place to deal with safety issues with medicines. Under this system, any new safety-related evidence that a Member State has, should be made available to the European Medicines Agency so that it can be assessed and appropriate actions can be taken to protect patients right across the European Union. At the current time the Agency has not received new evidence from any Member State in relation to venous thromboembolism associated with combined contraceptives. Any new information will be reviewed promptly.