Product information to be updated to help women make informed decisions about their choice of contraception

 

The European Medicines Agency has now completed its review of combined hormonal contraceptives (CHCs), particularly of the risk of venous thromboembolism (VTE or blood clots in veins) associated with their use. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of CHCs in preventing unwanted pregnancies continue viagra 100mg pills to outweigh their risks, and that the well-known risk of VTE with all CHCs is small.

 

The review has reinforced the importance of ensuring that clear and up-to-date information is provided to women who use these medicines and to the healthcare professionals giving advice and clinical care.

 

The product information of CHCs will be updated to help women make informed decisions about their choice of contraception together with their healthcare professional. It is important that women are made aware of the risk of VTE and its signs and symptoms, and that doctors take into consideration a woman’s individual risk factors when prescribing a contraceptive. Doctors should also consider how the risk of VTE with a particular CHC compares with other CHCs (see table below).

 

The review also looked at the risk of arterial thromboembolism (ATE, blood clots in arteries, which can potentially cause a stroke or heart attack). This risk is very low and there is no evidence for a difference in the level of risk between products depending on the type of progestogen.

 

The CHMP opinion, in agreement with the previous recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), will now be sent to the European Commission for the adoption of a legally binding decision to update the product information of all CHCs throughout the EU.

 

Risk of developing a blood clot (VTE) in a year
Women not using a combined hormonal pill/patch/ring and are not pregnant About 2 out of 10,000 women
Women using a CHC containing levonorgestrel, norethisterone or norgestimate About 5-7 out of 10,000 women
Women using a CHC containing etonogestrel or norelgestromin About 6-12 out of 10,000 women
Women using a CHC containing drospirenone, gestodene or desogestrel About 9-12 out of 10,000 women
Women using a CHC containing chlormadinone, dienogest or nomegestrol Not yet known1

1 Further studies are ongoing or planned to collect sufficient data to estimate the risk for these products.

 

Posted on the EMA website on 22 November 2013