This letter is to inform you of the results of a recent Europe-wide review and the latest evidence on the risk of thromboembolism in association with combined hormonal contraceptives (CHCs). The review concluded that:
- the risk of blood clots with all CHCs is small; updated progestogen-specific estimates of VTE incidence are provided in table 1 of annex 1.
- there is good evidence that the risk of VTE may vary between products, depending on the progestogen
- CHCs that contain levonorgestrel, norethisterone or norgestimate have the lowest risk of VTE
- the benefits of any CHC far outweigh the risk of serious side effects
- prescribers and women should be aware of the major risk factors for thromboembolism (such as older age, obesity, prolonged immobilisation, surgery, personal history of thromboembolism, smoking etc) and of the key signs and symptoms (see table in Annex 4)
The Summary of Product Characteristics and Patient Information Leaflet will be updated with the latest information and further information is provided in the attachments, including:
1. a prescribing checklist that may be used during a CHC consultation
2. a user information card and
3. a more-detailed information sheet that you may want to pass to women to read or to help in your consultation with them.