14th October 2013 - The European Medicines Agency (EMA) has rejected a request to tighten prescription guidelines for some oral contraceptive pills which have been linked with a higher risk of blood clots in arteries or veins.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed the evidence but decided there is no reason for women who have been using combined hormonal contraceptives (CHCs) without any problem to stop taking them.
However, it said women should be made aware of the risk of blood clots in the vein - known as venous thromboembolism (VTE) - and its signs and symptoms. Furthermore, doctors should take into consideration a woman’s individual risk factors when prescribing a contraceptive.
The review confirmed that the risk of blood clots with all CHCs is small and has shown that there are small differences between the CHCs depending on the type of progestogen they contain.
In February this year, France asked the Agency to modify prescription guidelines for so-called third and fourth generation contraceptive pills which were introduced in the last 2 decades. They are available as are available as pills, skin patches and vaginal rings. Evidence was reviewed for all CHCs containing the hormone oestrogen and some containing progestogen.
During the review, the risk of blood clots with these medicines was compared with that of CHCs containing levonorgestrel and norethisterone - also known as ‘second generation’ contraceptives.
Having assessed all the available data, the committee concluded that:
The risk is lowest with the CHCs containing the progestogens levonorgestrel, norgestimate and norethisterone: it is estimated that each year there will be between 5 and 7 cases of blood clots per 10,000 women who use these medicines
The risk is estimated to be higher with the progestogens etonogestrel and norelgestromin, with between 6 and 12 cases yearly per 10,000 women
The risk is also estimated to be higher with the progestogens gestodene, desogestrel, drospirenone, with between 9 and 12 cases yearly per 10,000 women
For CHCs containing chlormadinone, dienogest and nomegestrol, the available data are insufficient to know how the risk compares with the other CHCs, but further studies are ongoing or planned
For comparison, in women who are not using CHCs and who are not pregnant, there will be around 2 cases of blood clots each year per 10,000 women.
The review also looked at the risk of arterial thromboembolism (ATE, blood clots in arteries, which can potentially cause a stroke or heart attack). It decided that 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 committee is also recommending that the product information, including the package leaflet, should be updated to help women make informed decisions about their choice of contraception in partnership with their healthcare provider. In the meantime, women who have any questions or concerns should discuss them with their doctor at their next routine appointment.
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